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FibroGen Inc (FGEN) Q1 2019 Earnings Call Transcript

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FibroGen Inc  (NASDAQ: FGEN)
Q1 2019 Earnings Call
May. 09, 2019, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Welcome to the FibroGen First Quarter 2019 Financial Results Conference Call. My name is Erin and I will be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question-and-answer session. (Operator Instructions) Please note this conference is being recorded.

I will now turn the call over to Karen Bergman. Ms. Bergman, you may begin.

Karen Bergman -- Vice President, Investor Relations and Corporate Communications

Erin, thank you very much, and good afternoon, everyone, and thank you for joining our call. Today we are reporting financial results and corporate update for the first quarter of 2019. Joining today's call are Mr. Tom Neff, Chairman and Chief Executive Officer; Dr. Peony Yu, Chief Medical Officer; Dr. Elias Kouchakji, Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance; and Mr. Pat Cotroneo, Chief Financial Officer. Following our prepared remarks, Tom will discuss upcoming milestones and we'll open the call to Q&A.

During this call, you may -- we may make forward-looking statements regarding our business, including our collaborations with AstraZeneca and Astellas; financial guidance; the initiation, enrollment, design, conduct and results of clinical trials; our regulatory strategies and potential regulatory results; our research and development activities; and certain other business matters.

For risks and uncertainties regarding our business and statements made on the call today, as well as factors beyond our control that may cause differences between current expectations and actual results, we refer you to our annual report on Form 10-K for the fiscal year ended December 31, 2018, filed with the Securities and Exchange Commission. Copies of these filings can be found in the Investors section of our website. We undertake no obligation to update any forward-looking statement, whether as a result of our new -- of new information, future development or otherwise.

The format for today's call includes remarks from FibroGen's management team, and then we'll open the lines up to take your questions. The press release reporting our financial results and business update and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com. The webcast will be available for two weeks from today's date.

And with that, I'd now like to turn the call over to our CEO, Tom Neff.

Thomas Neff -- Chairman and Chief Executive Officer

Thank you, Karen. Welcome, everyone and thank you for joining us. Today, we are reporting on top line adjudicated results from the seven Phase 3 roxadustat studies performed by ourselves and our partners AstraZeneca and Astellas, including the MACE and MACE+ analysis, which is an important part of the overall benefit risk assessment regulators will perform.

These results are broken up into two safety pools, as agreed upon with FDA and EMA. There are 4,000 patients in the pool of CKD patients who are dialysis dependent, where roxadustat is compared to epoetin alfa and 4,300 CKD patients who are not on dialysis where we are compared to placebo.

We are also reporting results in the sub-group of incident-dialysis, representing patients who have recently begun dialysis and are not on ESA. This result is especially important, as this setting is the most suitable for the comparison of roxadustat in the current standard of care.

In the U.S. we believe that Major Adverse Cardiac Events, or MACE, endpoint defined as the time the first occurrence of death, myocardial infarction or stroke will be the primary basis upon which the FDA will assess the safety of roxadustat.

In Europe, we believe that MACE+, which consists of the defined MACE components plus hospitalization due to heart failure or unstable angina, will be the primary endpoint for safety assessment by European regulators.

In the EU, we have agreed with regulators on a non-inferiority margin. And in the U.S., we have had extensive discussions on this topic and expect to finalize standards in our pre-NDA meeting.

We'll discuss today some of the most important initial safety results based on the totality of data that we've analyzed to-date. In addition, we want to highlight important results from other clinical measures that we are analyzing such as change in renal function in non-dialysis patients as measured by change in eGFR, efficacy of roxadustat as compared to epoetin alfa and the presence of patient inflammation and relevant quality-of-life measures non-dialyst compared to placebo.

While the FDA and EMA will make their ultimate approval decisions upon their own analysis of benefit risk profile of roxadustat, the applicable patient population -- nonetheless, we and our partners believe the data is strongly supportive of the efficacy and safety of roxadustat.

I would now like to walk through our MACE and MACE+ results from the adjudicated pool of Phase 3 data, which have been reviewed by our -- with our U.S. partner, AstraZeneca; and our EU partner, Astellas.

In dialysis-dependent CKD, in the pooled analysis roxadustat was shown to be non-inferior to epoetin alfa and MACE+ analysis for the U.S., where there were several analyses. We believe there was no clinical meaningfully difference between roxadustat and epoetin alfa in MACE risk.

In incident dialysis, as noted above, we've examined the results from the incident populations who are patients immediately initiating dialysis approximately four months time before they initiate anemia therapy. We believe this dialysis subpopulation is the fairest setting for comparison of roxadustat versus ESA as this period of treatment has substantially increased levels of patient mortality, where the stable dialysis population continues between biopsies of patients who have survived the incident period and are already on stable doses of ESA after dose titration.

In incident dialysis, roxadustat demonstrated superiority to epoetin alfa and time to first MACE+ analysis. And the time to MACE analysis, there is a trend toward reduced risk for patients on roxadustat as compared to epoetin alfa. We would highlight for you this robust result of superiority came from the 1,500 patient pool with one to one randomization versus epoetin alfa.

In the NDD CKD population, 4,300 patients were randomized over three studies conducted by AstraZeneca, Astellas and FibroGen. These studies represent the first investigation in the CKD population where median eGFR levels are much lower than prior studies. This is a study that was started after FDA restricted the use of ESAs to below hemoglobin 10 and no retreatment at levels above 10.

In non-dialysis, roxadustat was shown to be non-inferior to placebo in time to first MACE+. In the MACE safety analysis of this population, we believe there is no clinically meaningful difference between roxadustat and placebo. Another way to view the NDD population results is to test the ITT analysis with long-term follow-up as a majority of patients in this pool followed through the end of the study. This is a conservative way to evaluate long-term safety in the NDD population.

Patients on roxadustat receive treatment for longer periods than placebo patients because some of the placebo patients drop out for lack of efficacy since safety data were also collected in the post treatment period. We were able to add an ITT analysis long-term follow up as a majority of the patients in this pool followed through the end of the study.

As to the intend to treat results in multiple analysis of both MACE and MACE+ MACE free survival and MACE+ free survival, CV MACE and CV MACE+, roxadustat was comparable to placebo. These results were below the commonly applied non-inferiority margin of 1.3. The ITT, a long-term follow-up analysis is one of several methods that have been discussed with the FDA to address the differential dropout rate.

As to -- apart from what makes data results -- sorry a correction, I have to make, which is that we have not yet spoken with FDA. There is a discussion plan with FDA about these various analyses, so it is planned to be not has happened.

All of these evaluations help to better understand additional benefits of roxadustat apart from a MACE and MACE+ safety analysis that is important to note that we enrolled a unique population, EGFR was from zero to 60 including even the sickest patients with median EGFR on the study pool between 15 and 20 as large prior studies such as treat were enrolling patients much healthier the first time a patient population the sick has been studied.

We have results in the EGFR versus placebo comparison for change in renal function over time, we evaluated where the treatment with roxadustat that could slow the rate of decline of renal function and clinically relevant matter, evaluations were performed across all NDD CKD populations, we also included the more conventional baseline cutoffs for non dialysis patients meaning the patients with EGFR above 10 as well as a population EGFR above 15, since receiving the un-blinded data after adjudication we've completed the one-year analysis of roxadustat versus placebo data evaluation and this study continues in the one-year data we have observed statistically significant slower rate of EGFR decline in the roxadustat treated patients versus placebo treated patients in the NDD pool, as well as both subgroups in the pooled analysis of EGFR change over time from the three NDD studies in patients with baseline EGFR above 15. They showed a treatment difference from baseline of 1.62 at 12 months.

We believe the results observed over time in this analysis suggests that the roxadustat treatment may slow renal function decline in a clinically meaningful manner. We are examining data in more detail, including stratify via level of disease progression, to understand the degree of difference and the impact of different subgroups at baseline over the longer term.

In other measures efficacy of roxadustat, we are pleased to have shown statistically significant improvement in a multiple standard quality of life measurements and to confirm roxadustat's efficacy in the presence of inflammation as measured by CRP where EPO requires increased doses over time. Dr. Peony Yu will describe these results in more detail later in the call. We are on track for roxadustat's submission for U.S. NDA, September, October time period, with the European MAA submission to follow.

Let me now turn to updates regarding China. Our NDA for roxadustat was approved in December 2018 by the National Medical Products Administration, NMPA, for the treatment of anemia caused by CKD in dialysis patients. We are pleased that all clinical site inspections for the Phase III non-dialysis study have now been completed by the Food and Drug Administration division, or CFDI of NMPA. And we expect the population of non-dialysis CKD patients to be added to the CKD anemia indication in the roxadustat label in mid-2019.

We continue to work closely with our partner, AstraZeneca, to prepare for the launch of roxadustat in China and have much to report in terms of progress. Our partner, AstraZeneca, has already initiated the aggressive build-out of a dedicated roxadustat field sales force covering five regions in China at launch, which will be fully deployed by mid-2019. FibroGen China's medical affairs field staff now numbers over 30 professionals. This info-market access team has been in place and active for over a year.

FibroGen is the marketing authorization holder, or MAH holder, in China that is responsible for pharmacovigilance. Our pharmacovigilance infrastructure in China, which includes a pharmacovigilance database and call center, has been active for over a quarter now. The commercial manufacturing readiness for both API and drug product is on schedule. We are confident about the third quarter China launch time frame.

A question we wanted to address is whether we'll be added to NRDL List, or National Reimbursement Drug List. We are hopeful that roxadustat may qualify for consideration in 2019 by virtue of receiving market approval at the end of 2018. To be clear, only our dialysis label can be considered as non-dialysis approval has not yet been received. Many factors go into our probability of admission in NRDL such as perceived unmet medical need, clinical value, pharmaco-economic value, pricing, which is to be agreed upon between the State Medical Insurance Agency and the sponsor. We believe NRDL is critical affordability for our patients, so this is a top priority for us.

Every effort is being made by the joint AZ and FibroGen team to maximize our chances of success. We expect to have a sense whether we'll be included and what price by some time in October. Finally, in Japan, our partner, Astellas, submitted NDA for roxadustat treatment of anemia in CKD patients on dialysis to PMDA last fall. The application is currently under review, and Astellas anticipates filing the supplemental NDA for the treatment of anemia in non-dialysis-dependent CKD patients in 2019.

With respect to expanded platform opportunities for roxadustat for the treatment of anemia in other disease settings, I'd like to take a moment to update you on our work with roxadustat in myelodysplastic syndrome or MDS.

We have completed the enrollment of 24 patients in open-label lead-in portion of our multicenter, multinational Phase 3 study in transfusion-dependent, lower risk patients with MDS. Encouraged by the positive results from the open-label portion, as measured by the proportion of patients who achieved transfusion independence, we have begun enrolling 160-patient, double-blind placebo-controlled portion of the study. Enrollment for the open-label portion of the China Phase 2/3 study is ongoing.

Turning now to pamrevlumab, our anti-CTGF antibody. We are extremely excited to see data reflected one year of treatment of our ongoing Phase 2 study evaluating treatment of acute pain muscular dystrophy in non-ambulatory patients. The data is supportive of earlier observed trends and examines multiple parameters of disease progression, including lung function, cardiac function, and muscle strength.

We believe that this data will show increase in function in certain parameters will support a pivotal study and we plan to discuss with the FDA in the near future. Dr. Elias Kouchakji will discuss these results in more detail shortly.

pamrevlumab recently received orphan drug designation for treatment of DMD. Our antibody now has orphan drug designation status in all three of the current indications; IPF, pancreatic cancer, and DMD and has received fast-track designation in IPF and pancreatic cancer.

Finally, I will briefly address financial matters here, and Pat Cotroneo, our CFO, will provide more detail later in the call.

In the first quarter of 2019, we reported $45.4 million of net loss or $0.53 per basic and diluted share in EPS. So, that's negative $0.53 per share. As of March 31, 2019, FibroGen had $712 million in cash.

I would now like to turn this over to Dr. Peony Yu for the discussion of the results from the CV safety pooled analysis and updates on the anemia program. Dr. Yu, please go ahead.

Dr. Peony Yu -- Chief Medical Officer

Thank you, Tom. For the roxadustat program, in the U.S. and EU, we are pleased to share with you the adjudicated cardiovascular pool safety analysis, topline results from the Phase 3 global roxadustat program. We see these results supporting safety of roxadustat in CKD patients. We also see other benefits beyond hemoglobin increase.

Our MACE and MACE+, we reiterate what Tom outlined earlier in what we are disclosing on the adjudicated safety data, MACE and MACE+ composite endpoints. MACE measures the number of patients with one or more adjudicated positive MACE events, which include death, myocardial infarction, and stroke.

The MACE+ composite endpoint has two more components in addition to the MACE, which now also add in heart failure and unstable angina requiring hospitalization.

The MACE composite endpoint is what we and our U.S. partner, AstraZeneca, discussed with the FDA for safety assessment. MACE+ is what we and our European partner, Astellas, agreed with EMA.

MACE+ has also been used extensively, in safety endpoint and assessment in CKD anemia trials as well as in some diabetes trial in both Europe and in the U.S.

Now what is adjudication? And why is it part of our process? Adjudication is the process of independently and objectively applying clinical standards to consistently determine individual events, qualified as MACE or MACE+ events.

To maintain objectivity, independent experts in cardiology, neurology and urology who are blinded to treatment assignment revealed the patient data and adjudicate the events relevant to their specialty.

To maintain data integrity, the process and documents are managed by an independent third-party. We conducted MACE and MACE+ analyses in the following patient pools.

Dialysis or non-dialysis. Incident dialysis, which is a population of dialysis patients who are just starting out to receive chronic dialysis treatment, and as well as in non-dialysis patient population.

In our dialysis pool of around 4,000 dialysis patients, based on the collective results of the various MACE and MACE+ safety analyses. We believe there is no clinically meaningful difference in MACE and MACE+ risks between roxadustat and epoetin alfa in the all-dialysis patient population.

And 95% of confidence interval of the hazard ratio is above -- I'm sorry, of that, 95% confidence interval of the hazard ratio is below 1.3, which is what the conventionally accepted measure, in such time to analysis of MACE and MACE+.

In the incident dialysis pool, consisting of over 1,500 patients, a subpopulation of the dialysis or non-dialysis pool which we believe offers a better setting for comparing roxadustat to epoetin alfa than the stable dialysis population.

Roxadustat demonstrate that superiority to epoetin alfa, in the time to first MACE+ in this subpopulation with fewer patients with MACE+ events was noted. In the time to first MACE analysis, there's a trend toward reduced risk for patients on roxadustat compared to epoetin alfa.

In our CKD non-dialysis pool of approximately 4,300 patients, in the multiple MACE and MACE+ pool, ITT analyses conducted in non-dialysis-dependent CKD patients, collectively, we believe there is no clinically meaningful difference in MACE and MACE+ risks between Roxadustat and placebo in non dialysis patients.

Now let's put these safety findings along with the reported efficacy results in clinical context. In our last earnings call, we reported that Roxadustat demonstrated the efficacy in meeting the primary efficacy end point of change in hemoglobin from baseline to mean hemoglobin average between weeks 28 to 52 in each of the seven Phase III studies conducted by Fibrogen and our partners.

For that all dialysis patient pool as reported previously not only was non-inferiority achieve in primary efficacy endpoints in all dialysis patients. Superiority in efficacy as demonstrated by a statistically significant larger increase from baseline hemoglobin level in Roxadustat treated patients than EPO patients was achieved in both HIMALAYAS study which is incident dialysis and in SIERRAS conversion dialysis studies.

In SIERRAS, Roxadustat treated patients achieve a more physiologic hemoglobin level of 10.7 grams per deciliter versus 10.2 in EPO arm, with a 33% reduction in red blood cell transfusion risk. We believe the lower achieve hemoglobin level in EPO compared to arm results from a combination of the lower target hemoglobin level on the ESA label due to FDA's concerned regarding ESA cardiovascular safety and EPO hyporesponsiveness in patients with the inflammation, as inflamed patients would elevated C reactive protein require higher doses of EPO than patients with normal baseline CRP levels, although they achieve lower mean hemoglobin level.

And as we understand from multiple publications that there is higher risk with higher target hemoglobin when one is using ESA while higher achieve hemoglobin in EPO has been confirmed to better safety, when the lower doses of EPO was used. Given the mechanism of our drug being uniquely different than EPO the -- being more physio -- being able to achieve a more physiologic hemoglobin level should translate into a benefit for patients.

Roxadustat efficacy measured in achieving hemoglobin level and dose requirement are not affected by inflammation status unlike in EPO. This important differentiation from ESA has been observed in multiple Phase III studies including in the U.S. based SIERRAS study which we believe is reflective of U.S. dialysis practice under current ESA labeling restrictions.

And we've also seen this differentiation in our China Phase 3 studies in dialysis patients. We have also observed a reduction of risk of red blood cell transfusion in our Phase 3 program. Although the roxadustat arm in conversion study start out at a disadvantage being exposed to patients for the first time and being compared to patients or optimize EPO dosing.

The roxadustat-treated patient showed significant reduction in red blood cell transfusion risk, as measured by time to first transfusion compared to patients receiving stable maintenance doses of epoetin alfa. Conversion patients comprise a majority in the dialysis or all dialysis patient pool. Yet, based on the key MACE and MACE+ analyses, we assess no clinically meaningful difference in the risk of MACE, MACE+ risk between roxadustat and epoetin alfa.

Next, the incident dialysis population is defined as patients who enter dialysis studies within 4 months of starting dialysis treatment. A vast majority of the incident dialysis patients were either ESA naive or had very limited prior exposure to EPO. During the transition from non-dialysis to dialysis in the first four months of dialysis treatment, patients suffer from mortality and hospitalization rate a twice those of dialysis patients survive the first year of dialysis treatment.

What's also relevant to roxadustat is that the initiation of dialysis often also coincides with the initiation of anemia therapy. We and our partners are very happy with the result of superiority to epoetin alfa in the time to first MACE+ and a favorable trend toward reduced risk for patients, roxadustat compared to epoetin alfa in time to first MACE analysis in the incident dialysis patient population. We believe roxadustat's favorable results in incident dialysis compared to EPO, could enable a safer treatment of anemia in CKD patients, initiating and continuing dialysis treatment.

Turning to CKD patients not on dialysis. In the CKD pool analyses from the three non-dialysis studies, roxadustat both consistently raised hemoglobin levels to a mean hemoglobin of 11 gram per deciliter in the roxadustat-treated patients and significantly reduced red blood cell transfusion compared to placebo. This is very important for patients to preserve their ability to have a kidney transplant later down the road, if they need to.

Importantly, roxadustat has shown the potential to preserve renal function as there was a statistically significantly smaller decline in EGFR in roxa treated patients than placebo, with a treatment difference of 1.62 in EGFR unit, when measuring change at one year from baseline in patients with baseline EGFR of 15 or higher, p-value is 0.0001 or a reduction of decline by 38% in EGFR relative to placebo arm.

We also observe statistically significant improvements in the various quality of life endpoints at 12 weeks from baseline, including the SF-36 vitality sub-scale with p-value that has three zeros followed by a two, SF-36 physical functioning subscale p-value of 0.0369, fat and anemia subscale with p-value -- and total score p-value of 0.0056, EQ-5D-5L VAS score with a p-value that has three zeros followed by a five in CKD patients not on dialysis.

Putting together these and other important potential clinical benefits with the safety results that we have seen, in comparison with EPO, which is a gold standard for safety measurement and in comparison to EPO which is the current standard of care in dialysis, but has some limitations, along with the convenience of a pill when treating patients with roxadustat to make treatment much, much more accessible than parenteral route of ESA.

We are excited about the potential of roxadustat as an innovative new therapy for CKD patients. We hope this provides some helpful context for you in understanding the significance of the safety top line results announced today.

Tom has already touched on the status of our U.S., EU submission plans. We and AstraZeneca will be in discussion with FDA on NDA submission plan, which we are targeting for September-October timeframe. We are also supporting Astellas MAA submission to EMA to be submitted thereafter.

For China, in April, CFDI inspected our China Phase 3 CKD non-dialysis study sites. We expect that the roxadustat label on CKD anemia there will be expanded mid-year to include non-dialysis, as well as dialysis patients. As Tom mentioned, we are excited about roxadustat's opportunity for market access via this year's NRDL election process in China.

In Japan, the NDA on roxadustat for treatment of anemia in dialysis-dependent CKD patients submitted by our partner Astellas, in September 2018 is now under review. We anticipate that Japan NDA decision later this year.

For the treatment of anemia in MDS patients, we have an ongoing Phase 3 study in transfusion dependent, lower-risk MDS patients in the U.S., Europe and Asia, plus another study, which is Phase 2/3 in non-transfusion dependent MDS patients in China.

Each has an open label run-in period. Anemia in MDS is notoriously difficult to treat, and we are striving to make a difference for MDS patients with roxadustat. We have completed enrollment of the first 24 patient in the open label portion of the U.S./European study. We and our partners are encouraged by the available results as there were large proportion of transfusion dependent patients able to achieve transfusion independence endpoint.

And we have already started dosing in the double-blind portion of the U.S./European Phase 3 MDS study. Finally, we are on track to start our first clinical trial in chemotherapy induced anemia with roxadustat. It's a Phase 2 study in the U.S. to be started shortly in 2019. I believe that all of us are aware and would like to do something about the under-treatment of anemia in patients who have undergone chemotherapy.

I like to now turn the call back over to Tom.

Thomas Neff -- Chairman and Chief Executive Officer

Thank you, Peony. Dr. Elias Kouchakji will now provide an update on pamrevlumab, including additional details on our DMD data, and update us on clinical development activities for pancreatic cancer and for IPF. Elias, please go ahead.

Dr. Elias Kouchakji -- Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance

Thank you, Tom. I will start with the Duchenne muscular dystrophy, as Tom mentioned. In mid-March this year, all 21 patients completed one-year treatment with pamrevlumab in our Phase 2 open label non-ambulatory Duchenne muscular dystrophy study.

Soon after, we initiated and administrative analysis of the data in the early second quarter of this year. This is in order to inform our clinical development strategy, and we reviewed this study later with key opinion leaders who are expert in this study of the critical function we tested in this study.

Starting with the pulmonary function test, the complete one-year results indicate a potential reduction in the rate of decline in FVC percent predicted from baseline in our study population, especially when compared to the data published in 2016 by Mayor (inaudible) in 2019.

As for the cardiac function test, the result as measured by LVEF, left ventricular ejection fraction, the data suggested a positive mean percentage change from baseline while the published data by MacDonell in 2018, showed a mean decline of approximately 1% from baseline in one-year.

Additionally, we've measured the cardiac fibrosis scores, and we collected the data. The published data by Tandem in 2015 showed a strong correlation between the cardiac fibrosis with LVF. Our data from the MRI fibrosis score suggests a similar correlation.

Similarly, in some of the muscle function test, the result of this test in this upper arm showed the mean change from baseline was smaller than the published data by Rico-T (ph) in 2019.

Base on this result and advice we received from our expert, we are planning to share these results with FDA to develop our clinical development plan for the Duchenne Muscular Dystrophy.

Moving forward with our other indication. We are planning on beginning enrolling in the Phase 3 double-blind placebo-controlled of pamrevlumab as neoadjuvant therapy for non-resectable locally advanced pancreatic cancer in the second quarter of 2019. We intend to enrol approximately 260 patients. Randomization of one-to-one to receive either pamrevlumab in combination with gemcitabine and nab-paclitaxel, or chemotherapy with placebo.

Also in the second quarter of 2019, we are on track to begin enrolling our double-blind placebo-controlled Phase 3 study of pamrevlumab in approximately 500 IPF patients. The primary efficacy endpoint is a change from baseline in forced vital capacity.

We are grateful for the opportunity represented by pamrevlumab in providing a needed therapeutic option for each of these three serious and progressive indication; duchenne muscular dystrophy, pancreatic cancer and idiopathic pulmonary fibrosis.

Thank you for listening. Tom, I'll turn the call to you.

Thomas Neff -- Chairman and Chief Executive Officer

Thank you, Elias. Pat Cotroneo, our Chief Financial Officer, will now discuss financial highlights for the first quarter of 2019. Pat, please go ahead.

Pat Cotroneo -- Chief Financial Officer

Thank you, Tom. As announced today, total revenue for the quarter ended March 31, 2019, was $23.9 million as compared to $31.9 million for the first quarter of 2018. For the same period, operating expenses were $72.7 million, and the net loss was $45.4 million or negative $0.53 per basic and diluted share, as compared to operating expenses of $72.5 million and a net loss of $41.4 million or negative $0.50 per basic and diluted share for the first quarter last year.

Included in operating expenses for the quarter ended March 31, 2019 was an aggregate non-cash portion totaling $20.2 million, of which $16.4 million was a result of stock based compensation expense as compared to an aggregate non-cash portion, totaling $12.5 million, of which $10.9 million was a result of stock based compensation expense for the same period in the prior year.

At March 31, 2019, FibroGen had $712.7 million in cash, restricted time deposits, cash equivalents, investments and receivables. As previously stated, our considered judgment is that the roxadustat NDA and MAA will be filed this year, which will trigger approximately $192.5 million in anticipated milestone payments of which the vast majority are associated with these filings.

Thank you. And I will turn the call back over to Tom.

Thomas Neff -- Chairman and Chief Executive Officer

Thank you, Pat. With the updates reported to you today, we advance a number of critical events in the coming months. It is our privilege to have shared with you today, roxadustat CV pool safety analysis results that we believe support submitting the NDA for both NDD and DD indications, treatment of dialysis-dependent and non-dialysis-dependent CKD to the FDA in September or October 2019.

In Europe, our partner Astellas anticipates submission of the MAA for dialysis-dependent and non-dialysis-dependent CKD later in 2019 November, December. In China, we expect to add non-dialysis-dependent CKD patients to the roxadustat label upon approval anticipated in mid 2000 -- Q3 2019. In Japan, Astellas is expecting a decision on NDA approval for roxadustat and dialysis-dependent CKD in fourth quarter of 2019.

For pamrevlumab, we look forward to updating you on our advancement to Phase III in LAPC and IPF and to further findings from our ongoing Phase II study in DMD for non-ambulatory patients.

With that, let me turn this back to Karen to begin the question-and-answer period.

Karen Bergman -- Vice President, Investor Relations and Corporate Communications

Thank you, Tom. Erin, please open up the lines for questions. Thank you.

Questions and Answers:

Operator

Thank you. (Operator Instructions) Your first question comes from Michael Yee with Jefferies. Michael, your line is open.

Michael Yee -- Jefferies -- Analyst

Hey thanks guys. Good afternoon. Tom and Peony, can you be very clear for us. I think there's some confusion around whether you are statistically non inferior in dialysis and non-dialysis on the MACE analysis, which is what is required for FDA. Can you confirm that or discuss that? And if you can also give us the hazard ratios for dialysis and non-dialysis on MACE that will be very helpful? Thank you.

Thomas Neff -- Chairman and Chief Executive Officer

Okay, so Michael, there's two parts to this answer. One is that in the European market, we are doing MACE+ where we have a statistical non-inferiority margin, a single margin identified and we are non-inferior in both measures. In the U.S. there are multiple non-inferiority margins that are under discussion. These are reflecting the fact that with not incident dialysis and with non dialysis dependent CKD patients. We are essentially addressing new indications that have not been investigated previously. So that incident dialysis in the CKD dialysis in discussions with our partner. They are very mindful of the phrase of totality of evidence.

And so they encouraged the idea that we address this in the form of the evaluation of results versus MACE where we did not see any clinically meaningful difference, means that it met the safety standards that people were looking for and that's why people are moving forward.

Michael Yee -- Jefferies -- Analyst

So to be very specific in dialysis and non-dialysis on MACE, are you trending the right way. Are you trending positive? What do you mean by not clinically means of differences?

Thomas Neff -- Chairman and Chief Executive Officer

Yeah I think I think the message there is, we're trending favourably, but at the same time we have to yet agree with our regulator on specific analysis to be done...

Michael Yee -- Jefferies -- Analyst

It was trending positive, but you just don't have an agreement on what the definition of which analysis you would like to have that it is trending positive.

Thomas Neff -- Chairman and Chief Executive Officer

Michael, I think that's a very fair way to say it.

Michael Yee -- Jefferies -- Analyst

Very good, OK. Thank you.

Operator

And your next question that comes from Andy Hsieh each with William Blair. Andy your line is open.

Dr. Peony Yu -- Chief Medical Officer

Before Andy, may I ask to Michael's response to Michael Yee's question? I just I don't know whether we made it very clear that when Tom and I use the number 1.3, we are talking about we're not talking about a hazard ratio. I want to make it absolutely clear that the hazard ratio for the MACE+ plus in the incident dialysis is way below 1. And it also is below 1 in dialysis, OK.

And the upper bound of the 95% confidence interval when you are below 1.3 that has been a commonly accepted statistical standard for non-inferiority and for us to state that, we are superior in time to MACE+ analysis in incident dialysis. What I mean is the upper bound of the 95% confidence interval is less than 1 and we have a -- when you compare the hazard between roxadustat to that of epoetin alpha, we have a very significant P value. So I hope this helps. But Michael does this answer your question.

Michael Yee -- Jefferies -- Analyst

Okay.

Dr. Peony Yu -- Chief Medical Officer

Okay. Andy.

Operator

Andy perhaps you're muted...

Karen Bergman -- Vice President, Investor Relations and Corporate Communications

Andy are you still on the call with us. This is Karen. We lost him. Proceed.

Operator

Your next question comes from Joel Beatty with Citi. Joe your line is open.

Joel Beatty -- Citi -- Analyst

Hi. This question is on the two pooled non-inferiority MACE analyses required by FDA. Was there a pre-specified statistical analysis plan agreed to with the FDA?

Dr. Peony Yu -- Chief Medical Officer

So Joel, we have had discussions with the FDA on how they will -- on the different method for statistical evaluation of safety endpoints. We believe that we have collected the data, that FDA would like to see. And we wanted to have -- be cautious in stating our agreement with the FDA because as we -- those of us who have interacted with the FDA oftentimes the reviewers would like to have the -- would like to look at the totality of evidence -- looking at both the safety as well as efficacy. And they -- the term that is used very commonly is called is a review issue. So it's not an issue, but it is -- if I were to review it, I would like to look at all the data before I would commit to a decision of -- on a drug. And so, I hope that answers your question.

Joel Beatty -- Citi -- Analyst

Okay. I understand.

Dr. Peony Yu -- Chief Medical Officer

And then to ensure alignment, we will be discussing with FDA on -- in our upcoming pre-NDA meeting to make sure that our preparation of the NDA package will provide the information that -- in a way that is sufficient for FDA to review.

Joel Beatty -- Citi -- Analyst

Okay. And then, a question on the non-dialysis MACE analyses. Did the event rate compare favorably to the comparator arm? And how -- in that analysis, how does it take into consideration the differences in the dropout rate?

Dr. Peony Yu -- Chief Medical Officer

Yes. We do -- so, first of all, Joel, that's a good question. So, we have -- because our drug is so efficacious and so well tolerated, patients really like staying on our drug. Now we all know that placebo doesn't work too well. So -- however, this is -- I want to go back and remind everyone that this is a double-blinded study. And so even -- so many patients -- these patients -- in other words patients are not -- do not have the treatment assignment information. We have many patients who are on placebo and on roxadustat who remain in the study to enable our long-term efficacy and safety evaluation. And even -- we did see a high -- a somewhat higher dropout rate in placebo-treated patients. However -- and to have some anticipation this could happen, we have collected safety data on patients during the post-treatment period. And that's why we are able to conduct the ITT analysis. And this will be, of course, the final assessment in -- and the statistics will be discussed with the FDA.

Joel Beatty -- Citi -- Analyst

Okay. Thank you.

Dr. Peony Yu -- Chief Medical Officer

And I just wanted to share that in the -- so we have mentioned in the ITT analysis in the non-dialysis patient population, it is -- would be considered a relatively conservative analysis. And the fact that we have -- we are able to show non-inferiority to placebo under such conditions really illustrates the strength of our drug's safety. And I wanted to also remind us that placebo is considered the gold standard for safety.

Thomas Neff -- Chairman and Chief Executive Officer

Okay. Go ahead. Andy, are you there?

Andy Hsieh -- William Blair & Company -- Analyst

Yes, I'm here. Can you guys hear me?

Thomas Neff -- Chairman and Chief Executive Officer

Yes.

Andy Hsieh -- William Blair & Company -- Analyst

Yes, I'm sorry, Tom and the team that I pressed the wrong button. So no -- yes, it caused a little confusion, so I apologize. So my question has to do with just looking at it from a big-picture perspective. You have -- on the MACE perspective non-clinically -- well, I guess -- no clinical difference between both arms, roxadustat versus EPO, roxadustat versus placebo.

But just -- this is from a -- I don't know if this is the correct way to think about it, but a transitive property of the quality, we know that placebo is not -- from a clinical perspective, does not equal to EPO. So, how do you kind of think about this discordance and what you just disclosed on the call?

Thomas Neff -- Chairman and Chief Executive Officer

Well, do this in a simpler groundwork on which is MACE+. And I'm doing this because we have very defined criteria of MACE+. The findings are, with incident dialysis pool, you have statistically significant advantage over ESA; with the entire dialysis pool, non-inferior; and then in NDD non-dialysis pool, you have non-inferior. So, you have these comparisons.

We think of the non-dialysis pool comparison to placebo, it's essentially similar. This -- the idea there is that it's hard to argue that there's an incremental safety risk. This placebo is what happens with CKD patients every day right now. They don't have medicines. So, it's not as if you can infer an incremental statistically proven risk in non-dialysis.

In the dialysis pool, the broader population, non-inferior and incident population, which we think is an unbiased comparison, we have statistical superiority. We don't expect that MACE will be particularly different than this. It's just that with U.S. we have an agreement with our partner, AstraZeneca, to evaluate on the totality of evidence basis. So, it makes it harder to sum this up in one sentence or two sentences. It's sort of a pretzel logic challenge to try to describe this accurately, but I think you can sort of look at the MACE+ results.

And from our point of view, if we thought the MACE results were going to be a lot different, we would say so. But it doesn't seem that way. It seems very similar. So, I would say, with the U.S., attributed to the fact that we do not have a single agreed endpoint -- one of the questions we asked with these newly defined populations in incident dialysis and in CKD was whether or not the entire analysis, the entire risk/benefit analysis should work a little bit differently than the conversion dialysis patients that have been using EPO forever. And the FDA basically said, that's a review issue. You need to spend some time showing us the benefit/risk analysis that you see from your data.

Dr. Peony Yu -- Chief Medical Officer

Yes, so Tom, I'll supplement this a little bit. I apologize, if we used too much of the statistics mumbo-jumbo. But I will -- I just wanted to add, even though we are saying that there's no clinically meaningful difference in MACE and MACE+ in our dialysis -- I'm just going to give one example, OK? And even though we are saying that, it is a very conservative way of expressing our data. In absolute terms, we have for example, in our dialysis pool, we have fewer patients. Now we look at on treatment analysis, and there are fewer patients who died on the roxadustat compared to EPO. We have fewer -- numerically fewer patients with a MACE event or with MACE+ events. So that's sort of I'm trying to give you a little color to what we are saying. It doesn't -- I hope this is helpful.

Andy Hsieh -- William Blair & Company -- Analyst

So just kind of digging deeper and helping us trying to understand the totality of data. Different components, death, MI, stroke. On top of that, unstable angina leading to hospitalization, heart failure. Can you confirm that all of these measures are trending in the right direction? Or maybe there's some that's not? Maybe can you comment on that?

Thomas Neff -- Chairman and Chief Executive Officer

So with the MACE+ data, I believe we have numeric advantages in these categories. There's 5 categories.

Dr. Peony Yu -- Chief Medical Officer

Each and single one of them Tom.

Thomas Neff -- Chairman and Chief Executive Officer

Every one of them we have a numeric advantage over ESA. Is that clear now?

Dr. Peony Yu -- Chief Medical Officer

We have advantage meaning lower.

Thomas Neff -- Chairman and Chief Executive Officer

Fewer events in roxa versus ESA and deaths. Fewer events in roxa versus ESA myocardial infarction. Fewer strokes in roxa than ESA. Fewer usstable angina hospitalizations. Fewer congestive heart failures resulting in hospitalizations

Andy Hsieh -- William Blair & Company -- Analyst

Yes. That's actually super helpful. Thank you for that. And just one last question about the quality-of-life measures. 12 weeks into that, given that this is a chronic condition, is that clinically relevant? Or should you be looking at a longer time frame?

Thomas Neff -- Chairman and Chief Executive Officer

It will be a quality-of-life study.

Dr. Peony Yu -- Chief Medical Officer

Yes. The quality-of-life number that I quoted was at 12 weeks. The quality-of-life measures is actually quite -- is quite difficult to measure over long term. And so -- and because you have -- you wanted to measure in the same patient population that you start out the study with. And also, on the subjective measures that where patient report to you how they feel, when you carry it over much longer period of time, there is patients -- not only patients, I may have forgotten how things -- how bad things were like a couple of months ago. And so generally, it is reasonable. Three months is a very reasonable period to report patient-reported outcome.

Andy Hsieh -- William Blair & Company -- Analyst

Great. Thanks for answering all my questions.

Operator

Okay. And your next question comes from Terence Flynn with Goldman Sachs. Terence, your line is open.

Terence Flynn -- Goldman Sachs -- Analyst

Hi, thanks for taking the question. Maybe just a follow-up. I think that your answer to the last question regarding the dialysis population was pretty clear, but in terms of the non-dialysis comparison of roxa versus placebo, I guess, I'm still a little bit confused in terms of how the -- I understand you didn't have a prespecified comparison. You're looking at it a number of different ways. But could you maybe just walk through how those event rates compare on MACE for roxa versus placebo across the different analyses. Were they all lined up? Were they all favorable? Was there anything out of line? And then when you look at the separate studies, again, I remember back from the amount of studies, they had one trial that they showed fewer events and one trial they actually had more events in the non-dialysis setting. So again, was there consistency across the three studies that you pooled as well? Thank you.

Thomas Neff -- Chairman and Chief Executive Officer

So Terence, we recognize that this is a terribly difficult area to state in a succinct manner, recall like this. Having said that and thinking about how to describe the situation most effectively, we decided to describe the ITT results. This is MACE, MACE+, MACE CV, time to MACE+, time to MACE. So there are several different measures. And in each case, the results of the analysis was at a ratio below 1.3, which is a standard non-inferiority comparison in ITT.

And so when I say below 1.3, I mean like 1.18 or 1.21 or 1.27 or 1.28, not above 1.3, but below 1.3. And I know speaking as someone involved in this partnership for a long time that people in each of our partner's executive management group, great confidence and strength in seeing these results because these are -- even though may be hard to measure that will ultimately be the ones that are evaluated, they are -- and ultimate safety evaluation standards FDA usually asks for whether you post it or not, so everybody felt like this is something that's very descriptive and very informative.

I would hesitate to do anything else beyond talking about the ITT results because we do not have a specific agreement with FDA on method of analysis. And as such, it's a little presumptuous. And I think the challenge for any of these statistics that would be like OT7 or OT28 or whatever is that you have a placebo dropout rate that's very different than the roxa stay on study rate. There is agreement from regulatory body that we can make statistical adjustments. We've gotten that in print from our reviewers. And there's certain things like covariance or IPCW adjustments that have been suggested as ways, that there's an acknowledgment this placebo dropout rate is an issue that needs to be evaluated. Peony, why don't you go ahead from there?

Dr. Peony Yu -- Chief Medical Officer

Yes. So FDA specifically suggested for us to do exposure-adjusted safety analysis. So if you have more patient exposure time on one arm than another, how do you compare the number of patients who have how many events? And so, when we -- so that's why the ITT evaluations one of the ways that we make such comparison. Another way will be exposure-adjusted to match the follow-up time on the two arms. And when we do that, we again see very, very reassuring safety data. And there's no -- and we see -- this certainly looks non-inferior in our assessment.

Terence Flynn -- Goldman Sachs -- Analyst

Okay. Can I maybe just ask a few follow-ups?

Thomas Neff -- Chairman and Chief Executive Officer

It's all right.

Terence Flynn -- Goldman Sachs -- Analyst

Sorry. Tom, please --

Thomas Neff -- Chairman and Chief Executive Officer

Terence, you get one more. What is it?

Terence Flynn -- Goldman Sachs -- Analyst

Okay. Sure. Just, again, so below 1.3. So that was for each of the three studies? Just to be crystal clear on that. Or that was on a pooled basis or talking about the non-dialysis population?

Dr. Peony Yu -- Chief Medical Officer

So --

Thomas Neff -- Chairman and Chief Executive Officer

This is all non-dialysis and its evaluations. MACE, MACE+, MACE CV. Peony, you want to add to that?

Dr. Peony Yu -- Chief Medical Officer

Yes. So -- Terence, the -- so the agreement we had with our regulators is that for MACE and MACE+ type of analysis will be based on pooled analyses across the three studies. And that is...

Thomas Neff -- Chairman and Chief Executive Officer

The three non-dialysis.

Dr. Peony Yu -- Chief Medical Officer

The three non-dialysis studies and with the total sample size of about 4,300 patients.

Terence Flynn -- Goldman Sachs -- Analyst

Okay. So you can't give us any more detail about the individual studies, I guess, at this point, in terms of what the individual numbers look like? Like, if they -- I'm just trying to understand if they're consistent across the three studies.

Dr. Peony Yu -- Chief Medical Officer

Okay. So, Terence, the -- there is consistency across the three studies, in that we met primary efficacy endpoints in all three studies in hemoglobin endpoints. And that we achieved transfusion superiority, which is clinically very important. And each of the -- none of the -- each of the individual study safety trends were -- overall safety trends were acceptable. And I just wanted to share that for MACE and MACE+ events, you need a certain powering statistics -- adequate statistical power to have meaningful comparison. So this is why we are reporting the pool result rather than individual study result.

Terence Flynn -- Goldman Sachs -- Analyst

Okay. Thanks so much. That was a lot clear. Thank you.

Operator

And your next question comes from Geoffrey Porges with Silicon Valley Bank Leerink. Geoffrey, your line is open.

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

Thank you very much and appreciate all the color that you're providing. Peony, could I ask you to pivot to the dialysis population? And you've broken out the incident-dialysis population where you seem to have superiority on MACE+ and trended benefit on MACE. Could you give us a sense of what you see in the stable dialysis patients, particularly, provide us reassurance that the number of -- whatever, however you manage it, the number of deaths, MIs and strokes in the stable dialysis patients who are switched to roxadustat still favors roxadustat? Because obviously, you don't have the same power or same apparent benefit in the pooled dialysis as you do in the incident.

Dr. Peony Yu -- Chief Medical Officer

Okay. Geoff, yes, I wanted to -- first of all, I think we agree that the conversion dialysis study design is biased against the study drug. But even so, when we look at subgroup analysis of the -- between incident dialysis versus the stable conversion dialysis, we are quite comfortable with the safety result when looking at MACE and MACE+. We -- does that help?

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

Could you provide the same -- is the rate of deaths, MI and stroke in that population lower in the roxa-treated patients?

Dr. Peony Yu -- Chief Medical Officer

Yeah. So I don't have the exact number sitting in front of me, but I would think that, from memory, they seem to be not that far from one another.

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

Okay. Peony, can I just follow up?

Dr. Peony Yu -- Chief Medical Officer

We have a lot of numbers here, Geoff.

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

I understand. Could you just talk about the overall rate of events that you're seeing compared to expectations? And also, were there any angiographic variances in the comparison depending upon geography, North America, Europe and et cetera?

Thomas Neff -- Chairman and Chief Executive Officer

Geoff, I'm sorry. Just a second. I want to -- Geoff, I want to give clarity on the question you just asked, but I think Peony wants to clarify one thing. Peony, go ahead.

Dr. Peony Yu -- Chief Medical Officer

Yes. So Geoff -- we -- when we tested the non-dial -- I wanted -- even though, I'm not giving you exact number of patients for each category, right, but I am willing to share with you that in the subgroup analysis, when we tested time to -- for example, time to MACE+ and MACE, roxadustat was at least non-inferior to epoetin alfa even in the conversion stable dialysis patients.

Thomas Neff -- Chairman and Chief Executive Officer

So if you take the subgroup of incident patients away, the remainder pool was tested as not inferior consistently.

Dr. Peony Yu -- Chief Medical Officer

Correct.

Thomas Neff -- Chairman and Chief Executive Officer

Now Geoff, please state the geography question again. Surprise Us. I don't think I heard the whole thing.

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

So I just want to -- could you just comment on the overall rate of events that you observed compared to expectations? And then whether there were any variations in the comparison between the different arms in the -- when you look at the subsets by geography?

Dr. Peony Yu -- Chief Medical Officer

Geoff, we are at this -- we are still on the -- releasing the top line results. The fine granular geographic subgroup analysis and more detailed analysis are -- still needs to be conducted. But we plan to begin now an NDA submission. It will be completed before then.

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

Okay. And the overall event rate or rates?

Thomas Neff -- Chairman and Chief Executive Officer

The question was, do you observe any difference overall subgroup by geography?

Dr. Peony Yu -- Chief Medical Officer

We have not done the subgroup analysis by geography yet.

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

Okay. Thanks very much,

Operator

And your next question comes from Difei Yang with Mizuho Securities. Your line is open.

Difei Yang -- Mizuho Securities -- Analyst

Hi. Good afternoon. And thanks for taking my question. I apologize upfront that I maybe a little slow. I'm trying to get some of the answers. So Tom and Peony, maybe you could help me think about three patient populations. There's the DD, NDD and incident dialysis. Is incident dialysis patient population as a possible indication in the U.S., I'm focusing on the discussion just for U.S. filing alone? Are we dealing with three patient populations in terms of getting approval? Or are we dealing with two, really, either it's DD or NDD?

Dr. Peony Yu -- Chief Medical Officer

So Difei, thank you. That's a very good question. We have already -- we have had initial discussion with the FDA regarding the 3 patient populations. And the understanding is that, the incident dialysis population is 1 that is -- I mean, the understanding is that all 3 patient populations for indication are under discussion that will be -- that is ongoing with the FDA. And we believe that the results will help drive the decision.

Difei Yang -- Mizuho Securities -- Analyst

Okay, thank you for that clarification. Now for the indication in the U.S., if we just think about DD and NDD for now, for the MACE, now we can forget about the MACE+ situation, just for the MACE measurement, have you reached statistical non-inferiority on -- again to either placebo or EPO?

Dr. Peony Yu -- Chief Medical Officer

So Difei, we -- so whether you reach statistically significant in non-inferiority, it really depends on what the non-inferiority margin is. And in Europe, we are more clear on the non-inferiority margin and we believe that we have achieved that. And for -- now for the incident dialysis, the nice thing about have achieving superiority is that no matter what the non-inferiority margin it is, once we can demonstrate superiority, we have already closed it.

And we are using the conventional standards of non-inferiority, which is widely published for assessment of CKD anemia and have previously been used by U.S. regulator for assessment of cardiovascular safety in similar types of composite endpoints that standard has been 1.3 for upper bound of 95% confidence interval. If we use that standard, the answer is yes, we have achieved non-inferiority. And so the reason that we are not as explicit in saying it is because we wanted to be transparent when we state what we mean by non-inferiority. I hope this helps.

Difei Yang -- Mizuho Securities -- Analyst

This is very, very helpful. So, then, if I could ask a question on quality-of-life measurement, do you see superiority or non-superiority on the ID and DD patient population? I think NDD, you said, you achieved superiority. Is that the right understanding?

Dr. Peony Yu -- Chief Medical Officer

So, Difei, the reason that we focused on testing quality of life in non-dialysis is that we are testing against placebo, and we do a superiority testing. In dialysis, it's not as meaningful because when we are comparing against an active comparator that clearly does not have a label for quality of life. I mean, even if you're non-inferior, what does that mean? It's not going to get us a label and trying to go for superiority, that doesn't make sense either. So that's why we focus our quality-of-life measures in the non-dialysis patient population.

Thomas Neff -- Chairman and Chief Executive Officer

So just to be clear, we only tested quality of life in non-dialysis, 4,300 patients in non-dialysis, not in dialysis. Okay?

Difei Yang -- Mizuho Securities -- Analyst

Okay. Thank you. That's very helpful. And my final question is that it sounded you plan to file NDA September, October time frame. But before then, there will be FDA meeting. Could you update us, or do you have plans to update the investors before the NDA submission when you have more clarifications on the data analysis, et cetera?

Dr. Peony Yu -- Chief Medical Officer

So, Difei, I'm looking at my colleague heading regulatory, and we normally do not do press release before or necessary when we go see the FDA. However, we will certainly update our investors when we submit NDA. And I see him nodding his head.

Thomas Neff -- Chairman and Chief Executive Officer

And I would also say if there is a meaningful change in the timeline assumptions, which are now September, October submission time, we will let investors know.

Difei Yang -- Mizuho Securities -- Analyst

Okay, thank you. This is very helpful.

Operator

Okay. And your next motion comes from Adam Walsh with Stifel. Adam, your line is open.

Edwin Zhang -- Stifel -- Analyst

Hi. Thanks for taking my question. This is Edwin Zhang on for Adam. Congrats on the data. A couple of questions for me. First, based on this MACE data, how do we think of the label language if approved? Are we confident to avoid a black box?

Dr. Peony Yu -- Chief Medical Officer

Adam, thank you for -- Oh, you, Edwin. Okay. Sorry, Edwin. So thanks for the questions. Now when -- now what FDA puts on the label is something that they -- that we may not have much control over except that we have developed a package that will target a certain label. And so we -- FDA has advised us that the evaluation of efficacy -- primary efficacy, will be based on individual studies. And we have checked that box. And the evaluation of safety is, you know, FDA may -- will look at various aspects of safety. And based on what we have seen, we are pretty comfortable with safety.

This adjudicated composite safety endpoint was something that we have discussed with the FDA. And at this time, we are quite happy with the results. The fact that we believe that the CV safety endpoint in our studies in the non-dialysis, when compared to the gold standard of placebo, we are now seeing increased risk. That makes me think that we have a chance of avoiding us, some of the -- those terms that is currently on the EPO label. However, this is what we are targeting when we selected placebo as a comparator. But at the end, the assessment is really -- depends on the medical review at the FDA. And there will -- if there were an advisory committee, then there will be input from the advisory committee if the FDA chooses so.

Edwin Zhang -- Stifel -- Analyst

Okay. In term of the totality of the data, the additional positive benefit in NDD is impressive like a slower EFR decline, the quality of life or even efficacy in the inflamed patients, which are opting in the EPO equal treatment. What do you think of -- the agency you look at this benefit from roxa? Do you think that you'll have to open a larger market for roxa in NDD?

Dr. Peony Yu -- Chief Medical Officer

Yes. So this is a great question. We have discussed with FDA on how to look at the drug. And the FDA has explicitly advised us that benefit will be taken into consideration as they evaluate each drug based on the combination of benefit risk. And we are hopeful of being able to reach more CKD patients in need with this highly accessible drug that is just a pill and not have to go drive to the doctor's office regularly to get shots.

Edwin Zhang -- Stifel -- Analyst

And when do we expect to see the full MACE data?

Dr. Peony Yu -- Chief Medical Officer

We are -- that's a very good question. Right now, we are sharing with you some very, very top-level results. And we'll be in discussion with our partners to -- so there are two key places where we'll be sending the full MACE data. One is to the health authority to try to get the drug approved. And two, submit to major conferences. And since we just got the data, we are in discussions with partners, on which conference, and which journal to submit manuscript to.

Edwin Zhang -- Stifel -- Analyst

Okay.

Dr. Peony Yu -- Chief Medical Officer

I'm sure it will be a lot of fun.

Edwin Zhang -- Stifel -- Analyst

Also one question on DMD. I don't wanted it to overshadowed by the MACE question.

Thomas Neff -- Chairman and Chief Executive Officer

Thank you.

Edwin Zhang -- Stifel -- Analyst

When are we going to see the data, the DMD data? And from the next study, what is your planed dosing regimen, the mean point? And what kind of control arm you will use? Thank you.

Thomas Neff -- Chairman and Chief Executive Officer

Yeah. So I think there is a lot to talk about here. An important idea is the left ventricular ejection fraction, LVEF. We have positive numbers. This is a big deal, right? But in terms of what's going to happen next, I will let Dr. Elias Kouchakji speak to this plan.

Dr. Elias Kouchakji -- Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance

So, as we talked and mentioned by Tom, that we are as fresh as we are looking to go and talk with the FDA about the next step with this data. And at the same time, we are looking to collect this additional natural disease history data, which is very important. And then from there we, hopefully soon after, we will be publishing our data. And that's when disease -- our data that we collected in this patient population. We are looking for the earliest conference ass possible where we could bring some of our data out, which is most likely will be during the World Muscle Society.

Edwin Zhang -- Stifel -- Analyst

Great. Thank you.

Operator

Okay. And we have no further questions at this time. So, I would like to turn the call back over to Tom Neff for closing remarks.

Thomas Neff -- Chairman and Chief Executive Officer

Thank you all for joining us on this call today. These data represent the culmination of many, many years of hard work on the part of our team in FibroGen, in some cases, measuring a decade or more.

Thank you all for your dedication to and belief in our program. We actually believe we have very good data. I also would like to thank all the physicians, investigators and patients who participated in the clinical development programs, our collaboration partners and our investors for patience and continued support. We look forward to keeping you updated on our progress throughout 2019. I'd like to wish everyone a good afternoon, and thank you for joining our call.

Operator

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.

Duration: 92 minutes

Call participants:

Karen Bergman -- Vice President, Investor Relations and Corporate Communications

Thomas Neff -- Chairman and Chief Executive Officer

Dr. Peony Yu -- Chief Medical Officer

Dr. Elias Kouchakji -- Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance

Pat Cotroneo -- Chief Financial Officer

Michael Yee -- Jefferies -- Analyst

Joel Beatty -- Citi -- Analyst

Andy Hsieh -- William Blair & Company -- Analyst

Terence Flynn -- Goldman Sachs -- Analyst

Geoffrey Porges -- Silicon Valley Bank Leerink -- Analyst

Difei Yang -- Mizuho Securities -- Analyst

Edwin Zhang -- Stifel -- Analyst

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