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Edited Transcript of CRMD earnings conference call or presentation 13-Aug-19 8:30pm GMT

Q2 2019 CorMedix Inc Earnings Call

Summit Aug 20, 2019 (Thomson StreetEvents) -- Edited Transcript of CorMedix Inc earnings conference call or presentation Tuesday, August 13, 2019 at 8:30:00pm GMT

TEXT version of Transcript


Corporate Participants


* John L. Armstrong

CorMedix, Inc. - Head of HR & Executive VP of Technical Operations

* Khoso Baluch

CorMedix, Inc. - CEO & Director

* Phoebe Mounts

CorMedix, Inc. - Executive VP & General Counsel

* Robert W. Cook

CorMedix, Inc. - CFO


Conference Call Participants


* Raghuram Selvaraju

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Daniel Ferry

LifeSci Advisors, LLC - MD & Relationship Manager




Operator [1]


Good day, ladies and gentlemen. And welcome to CorMedix Second Quarter 2019 Earnings Conference Call. (Operator Instructions)

At this time, it is my pleasure to turn the floor over to Mr. Dan Ferry. Sir, the floor is yours.


Daniel Ferry, LifeSci Advisors, LLC - MD & Relationship Manager [2]


Good afternoon, and welcome to the CorMedix Second Quarter 2019 Investor Conference Call. Leading the call today is Khoso Baluch, Chief Executive Officer of CorMedix. He is joined by Bob Cook, Chief Financial Officer of CorMedix; Phoebe Mounts, Executive Vice President and General Counsel; and Jack Armstrong, Executive Vice President, Technical Operations.

Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meanings set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following: Any statements other than statements of historical fact regarding management's expectations, beliefs, goals and plans about the company's prospects, including its clinical development program for Neutrolin in the U.S. and other product candidates; future financial position; future revenues and projected costs; and potential market acceptance of Neutrolin and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost, results and interpretations, thereof; projections as to the company's future capital raising and spending and cash position; expectations as to the timing and nature of anticipated regulatory actions; possible product licensing or other business development transactions; any commercial plans and expectations; market projections for our product candidates; and expectations as to manufacturing and product component costs.

Actual results may differ materially from these projections or estimates due to a variety of important factors, including, but not limited to, uncertainties related to clinical development, regulatory approvals and commercialization. These risks are described in greater detail on CorMedix filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix.

CorMedix may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. Please note that CorMedix does not intend to update these forward-looking statements, except as required by law.

At this time, it is now my pleasure to turn the call over to Mr. Khoso Baluch, Chief Executive Officer of CorMedix. Khoso, please go ahead.


Khoso Baluch, CorMedix, Inc. - CEO & Director [3]


Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. Today's earnings call will focus on our continued efforts to bring Neutrolin to the U.S. market as a catheter-lock solutions for hemodialysis patients and the commercial opportunity that we've analyzed for the catheter-lock solution.

For this call, I have Bob, Phoebe and for the first time, Jack Armstrong, joining me. Paul and Liz are not joining this call but are busy at work.

We will cover 4 topics during this call. First, an update on the significant progress we've made on the regulatory pathway for Neutrolin directed at filing a marketing application for a new drug, or NDA. We will then talk about chemistry manufacturing and control information of CMC, which is a major component of the NDA and the work currently underway to establish the supply chain for the U.S. market. We will then talk about Neutrolin's commercial opportunity in the U.S. as the catheter-lock solution, not only for hemodialysis but also for additional indications for use. And we will then provide you an update on the company's financial position.

With that, let me hand over to Phoebe.


Phoebe Mounts, CorMedix, Inc. - Executive VP & General Counsel [4]


Thank you, Khoso. It is a pleasure to be here and to be able to provide you with an update on our progress on the regulatory activities required to bring Neutrolin to the market in the U.S.

During the last earnings call, I emphasized our ongoing discussions with the FDA on the clinical data generated in our clinical trial LOCK-IT-100, and its efficiency of provide substantial evidence of safety and effectiveness of Neutrolin to prevent catheter-related bloodstream infections in hemodialysis patients.

Without a doubt, adequate evidence from clinical trials is the most significant milestone for an Investigational New Drug and warrants the emphasis that sponsors and the FDA place on ensuring robust and reliable data to protect patients who will be using the drug and provide accurate prescribing information to physicians in the practice of medicine. Without successful clinical trial data, an Investigational New Drug progresses no farther towards commercial distribution. We were very pleased to be able to announce in a press release on July 9 that based on CorMedix's communications with the FDA, the company has completed Phase III of clinical development for Neutrolin in hemodialysis patients. What this means is that a second clinical trial in hemodialysis patients will not be conducted. This means that we have saved more than 2 years and millions of dollars by not needing a second Phase III study.

Assuming that Neutrolin is approved, we will be able to prevent catheter-related infections to save lives and begin generating revenue earlier than anticipated.

As Khoso will discuss later on the call, CorMedix believes that Neutrolin has the potential to be a best-in-class product without any serious competition in sight.

As we covered in our last earnings call, considerable data were generated from the almost 800 study subjects in LOCK-IT-100 and we focused our discussions with FDA on providing it with the information requested to continue evaluating the primary and secondary efficacy endpoints. We compiled additional data and information on the procedures and assessments conducted by the Clinical Adjudication Committee for confirmation of catheter-related bloodstream infections for the primary endpoint analysis. Additional analyses and information were also requested for the secondary endpoints. These analyses were prepared and submitted to the FDA, and we are pleased to report that the FDA did not have any further questions on the information that was provided to it.

Any remaining questions will be addressed when full report on LOCK-IT-100 was submitted to FDA in the NDA. We are continuing to work on completing all of the trial documentation required in the trial master file and on drafting the clinical study report for the NDA. It is tremendous news from both the timing and expense standpoint that another Phase III trial does not need to be conducted before submission of the NDA for an indication for use of preventing catheter-related bloodstream infections in hemodialysis patients. We believe that it is also great news for individuals who are on dialysis that Neutrolin may be available to them sooner if we can secure approval from FDA. Just to be clear, additional indications for use that will be described by Khoso for oncology and TPN were not included in the LOCK-IT-100 clinical trial and will not be part of the NDA being prepared.

We have had discussions with FDA on clinical trial designs for use as a catheter-lock solution in oncology and TPN and are working to develop the protocol with the goal of finalizing the regulatory pathway for these patient groups after the NDA for hemodialysis is filed.

It is important to keep in mind that in addition to the clinical evidence, the NDA requires extensive manufacturing information, including methods used in manufacturing the drug and the controls used to maintain the drug's quality, to ensure the drug's identity, strength and purity. The discussions with FDA on CMC information began before the filing of the Investigational New Drug application for Neutrolin and were reviewed by FDA to obtain approval from FDA to initiate LOCK-IT-100.

The safety of the study subjects demands quality control before exposure to investigational drug products. However, FDA's regulations do not prescribe in detail how a manufacturer must proceed as it designs and manufactures a specific drug product, which will obviously be dependent on the chemistry and formulation of the drug. Just as we have been engaged with FDA on clinical data to support safety and effectiveness of Neutrolin, we have been engaged in discussions with FDA on CMC information.

During clinical development, the manufacturing process must be scaled up and variations in the drug substance and drug product may be introduced. Manufacturing of the drug product must be shown to be reproducible and reliable through validation studies. Stability of the product needs to be demonstrated with extensive data and subjected to conditions likely to be encountered in commercial distribution to ensure the quality of the product. Jack Armstrong will describe these activities in more detail, but guidance from FDA is critical throughout the development process to ensure that FDA's expectations are addressed and problems are minimized during NDA review. We are planning to meet with FDA in the fourth quarter to discuss the CMC information, which is just as important for a successful NDA as the clinical data.

After the CMC meeting, the next step towards filing the NDA is a pre-NDA meeting with the FDA. The purpose of the pre-NDA meeting is to finalize agreements with FDA on the administrative details for the actual submission of the NDA. If care is not taken in preparing the information required in the NDA, FDA may determine in its initial 60-day review period that the NDA is not complete and FDA will refuse to file the submission.

One of the topics for the pre-NDA meeting will be the availability of the LPAD Pathway, or Limited Population Pathway for Antibacterial and Antifungal Drugs, for approval of the NDA. We were told by FDA that approval pursuant to LPAD is a topic for discussion at the pre-NDA meeting. You may recall that this pathway provides the FDA with additional flexibility in its determination of safety and effectiveness and takes into account the severity and prevalence of the infection the drug is intended to treat and the lack of alternative treatment in the limited population for whom the drug is intended for use. We will continue our discussion of LPAD at the pre-NDA meeting with FDA.

I would like to note that we had the opportunity to participate in FDA's public meeting on LPAD on July 12, and we are grateful to FDA for allowing us to present our comments on how we think the program can be strengthened to better serve the public health and industry. FDA is currently revising the LPAD guidance and we have also filed comments to FDA's docket to emphasize the need to make an affirmative determination for eligibility for LPAD earlier in product development.

Another important topic for discussion at the pre-NDA meeting will be securing programs designed to expedite the review of the NDA. For example, we have received fast-track designation for Neutrolin and that makes the NDA eligible for priority review. Request and approval for priority review must be received from FDA in advance of submitting the NDA. If the FDA agrees to priority review then the goal for the review period by FDA is 6 months instead of the standard review period of 10 months. Just to be clear, the review periods are goals for the agency and not absolute time lines.

Based on our current estimates, we are anticipating that the NDA may be approved during the second half of 2020. Once we have our pre-NDA meeting with the FDA completed in the fourth quarter, we will refine our estimates if required. As I stated during the last earnings call, I'm excited about our progress in developing the information needed to secure marketing authorization for Neutrolin in the U.S. and confident that internally, we have the team and capabilities to be successful.

With that, I would like to turn the call over to Jack, who will provide you an update on the CMC work and supply chain for the U.S. Jack?


John L. Armstrong, CorMedix, Inc. - Head of HR & Executive VP of Technical Operations [5]


Thank you, Phoebe. My name is Jack Armstrong, and I have been associated with CorMedix for the last 4.5 years: First as an adviser; and since 2017, as a full-time employee as EVP for Technical Operations.

For those of you who do not know me, I would like to share a little bit of my background. After college and serving in the U.S. Army, I began my 45-plus year career in the pharmaceutical industry working for Merck. In my years in the pharma industry, I have been very fortunate to have worked in both big pharma and small pharma companies. For the past 30-plus years, my roles have been related to CMC, manufacturing and drug development as well as serving in senior executive positions, including as CEO of several companies.

Now let's get focused on Neutrolin. CorMedix has been manufacturing and selling Neutrolin outside the U.S. for the last 5 years. We have successfully carried out technical transfer and validation of the manufacturing process, which is -- which has enabled the successful production of product at 3 different manufacturing sites. This should give you comfort that we understand Neutrolin's manufacturing, technical, analytical processes as well as the quality controls and the systems that go with it.

I have working with me a very experienced and competent team that has the needed breadth and depth and the requirements for sourcing, manufacturing, distribution and quality control that is necessary for both the U.S. and foreign markets. And importantly, the key members of my staff, including me, have in our past experience successfully submitted multiple NDAs that were ultimately approved. As Phoebe has said, our interactions with the FDA concerning product manufacturing have been proactive and positive. We have no reason to believe that we cannot fulfill the requirements that the FDA has outlined.

Many companies, particularly small, inexperienced companies, overlook the importance of the CMC section that is required for the NDA. At CorMedix, we have not done that. We have been diligently working and interacting with the FDA on this topic continually during the product development in the U.S. As Phoebe explained, the regulations provide the framework for the quality that must be designed and built into the pharmaceutical product. But the specific manufacturing process and demonstration of quality must be created by the sponsor with guidance from FDA based on the particular drug and its intended use.

CorMedix has been working diligently to develop the CMC information required for FDA review and approval for commercial distribution based on guidance from FDA. Our press release of July 9 was an update on our ongoing discussions with FDA to ensure that all the CMC information required for the NDA will be in place. It was intended to be a clear signal from CorMedix to life science investors that we understand the importance of manufacturing data and that we are on top of it.

In addition, we are now in the process of finalizing the supply chain and distribution network for the initial product that will be used for launch in the U.S. The initial finished product will be manufactured in Europe. Further, we expect to qualify a second third-party manufacturing site in North America. Longer term, based on our preliminary forecast, we expect to be manufacturing at 2 or more contract manufacturing sites in order to supply the volume of products needed to meet our forecast for U.S. market.

We have selected our active drug substance suppliers, also known as API, and built our manufacturing infrastructure and supply chain to be both robust and efficient. Further, we have also worked hard over the last several years to address Neutrolin's cost of goods. I'm very pleased at the progress we have made, and while I'm not able to provide further details on this call, I can say that our production costs will generate pharma-like gross margins on U.S. sales.

So in summary, very pleased with our progress and believe we are on track for our CMC filing.

I'll now turn the call back over to Khoso.


Khoso Baluch, CorMedix, Inc. - CEO & Director [6]


Thanks, Phoebe and Jack, for describing clearly important work for CorMedix as we continue to move forward in the next phase for Neutrolin.

Now let me cover some exciting insights. During the last several quarters, CorMedix updated its understanding of the market opportunity and the evolving reimbursement environment for Neutrolin in the U.S. CorMedix undertook several studies, including extensive interviews with almost 180 nephrologists, oncologists, TPNs, healthcare providers and nurses in each of the segments, plus peers covering all the different sectors involved with reimbursement.

The work that was previously done is several years old, and we wanted to ensure that our understanding of the market includes current standard of care in the various indications and the impact of the current therapies on the need for catheter-lock solutions. As a result, we believe we would be better prepared to meet the need of the patients and the caregivers should the FDA approve Neutrolin in the U.S. Our work has reinforced our belief that the medical need is substantial. Nurses and physicians agree that a catheter-related infection is the most clinically concerning complication associated with central line use. Neutrolin's profile, as we now know based on our Phase III study, is clearly a game-changer. And we are convinced that it has the potential to be a best-in-class product. We have reconfirmed the significant unmet medical need and that practitioners consider current solutions inadequate. Healthcare providers are seeking a better solution.

Based on the research, Neutrolin received very high acceptance ratings within all segments and by all healthcare providers. This clearly positions Neutrolin as a popular solution for preventing the catheter-related bloodstream infections that so many patients and healthcare providers dread.

In fact, based on the current market research with nurses and physicians, the interest in Neutrolin product profile was very high. The market research was conducted by a firm that has done similar research on over 100 new products and their receptivity to Neutrolin was among the top 10% of all products tested across many disease states and treatment modalities, including very innovative products such as cell therapy.

CorMedix also undertook a deep and detailed analysis of the 3 segments of the catheter-lock solution. The segments that were studied were hemodialysis, oncology and TPN. The ICU segment requires further work. The size of these catheter-lock solution markets was assessed in detail as it's not easy to determine the number of catheter-lock solutions used in each of these markets or in any of the segments within these markets. There is no available IMS data or Omnibus Report that accurately captures this information in the U.S.

CorMedix's cross-functional team of medical affairs, regulatory, supply chain, finance and commercial participated. The outcome revealed some interesting findings. The market for catheter-lock solutions in the hemodialysis segment was estimated to be around 40 million catheter-lock solutions per year and growing. The oncology and TPN segments were estimated to be almost 150 million catheter-lock solutions per year and also growing. This information separates catheter-lock solutions from flushes, which sometimes are misunderstood and in -- combined into as catheter-lock solutions. We believe that based on today's practice, saline would be used as a flush, followed by catheter-lock solution. What is also interesting is that while primary access route for hemodialysis is a central venous catheter, in the oncology segment, catheters with POS are most often used instead.

Having gained further insight between the hemodialysis and oncology market, we have learned how we can address the needs of these different markets with variation and product presentation and packaging in a way that allows us to tailor our product and our pricing to best address the value in these different market segments.

A separate CorMedix work effort examined reimbursement and the burden of CRBSI in the hemodialysis patient population. The focus was on value pricing and the impact on different budget holders. Time was also spent understanding the legislation that was initially issued in the summer of 2018 called TDAPA, that stands for transitional drug add-on payment adjustment for end-stage renal disease. What this will provide is for Neutrolin to be eligible for reimbursement outside of the ESRD bundle for at least the first 2 years. CMS last year expanded eligibility of the TDAPA to include all new drugs biologicals, including generic drugs.

CMS just last month released a new proposal for 2020. CMS is proposing to narrow the eligibility criteria to exclude drugs and biologics approved under certain types of FDA approvals. In general, drugs with approvals as new molecule entities, new active ingredients and a new drug-to-drug combination and new biologics would still remain eligible for TDAPA. Neutrolin falls within this criteria as a new molecule entity and should therefore be eligible for TDAPA. This TDAPA applies for the hemodialysis patients only. The oncology, TPN, which is total parenteral nutrition segments, are quite different.

In these segments, the large majority of patients are treated as outpatients. On a fee-for-service model, ASP plus, while a smaller group are treated in hospital in which the reimbursement is generally via capitated payment system, based on DRG codes. The reinvestment in the outpatient oncology and TPN is generally more leveraged, in other words, higher priced, for value due to the higher incidence of CRBSIs. There is still a lot more work to be done before we can finalize our pricing strategy.

Work such as budget impact, health economics, value messaging and payer strategy will need to be completed in order to refine and optimize CorMedix strategy for Neutrolin launch in the U.S.

Let me be clear. Our goal is to maximize shareholders' value because hemodialysis is a very concentrated payer-provider market, we are continuing to prepare CorMedix to launch Neutrolin in the hemodialysis segment, while at the same time being open to potential partnerships.

We are now beginning the process to recruit into CorMedix the commercial market access and medical affairs leadership for the U.S. market. We also acknowledge, particularly in the area of oncology, TPN and critical care, that these areas are very broad and therefore would be more appropriate that a larger more strategic player who already is in this space, be best able to maximize shareholders' value.

Now let me at ask Bob to cover quarter 2 finance and CorMedix's finances.


Robert W. Cook, CorMedix, Inc. - CFO [7]


Thank you very much, Khoso. The company expects to file its report on Form 10-Q for the second quarter and 6 months ended June 30, 2019 tomorrow. I urge you to read the information contained in the report for a more complete discussion of our financial results.

With respect to our second quarter 2019 financial results, our net loss was approximately $0.7 million or $0.03 per share compared with a net loss of $8.6 million or $0.52 per share in the second quarter of 2018. During 2019 second quarter, we recorded the sale of our New Jersey net operating losses resulting in cash proceeds of $5.1 million. R&D expenses declined significantly, while we recorded an increase in SG&A expense.

Operating expenses in the second quarter of 2019 declined 35% to $5.5 million compared with $8.5 million in the second quarter of last year. R&D expense declined approximately 55% to $3 million from $6.6 million mainly due to a $4.7 million decrease in clinical trial expense, partially offset by $1 million increase in CMC-related activities.

SG&A expense increased 32% to $2.6 million compared with $1.9 million in the second quarter of 2018. Higher compliance expenses, staffing, consulting and marketing expenses were partially offset by a reduction in legal fees, patents and investor relations expenses.

We recorded positive cash from operations during the second quarter of this year of $0.2 million as a result of lower operating expenses and the cash received from the sale of our New Jersey NOLs compared with cash used in operations of $4.3 million in the second quarter of last year.

With respect to our financial results for the 6 months ended June 30, 2019, our net loss was approximately $5.9 million or $0.25 per share compared with a net loss of $18.7 million or $1.19 per share for the 6 months ended June 30, 2018.

Operating expenses during the first half of this year amounted to $10.4 million compared with $18.7 million in the first 6 months of 2018, a reduction of 44%. R&D expense declined 61% to $5.9 million as a result of the wind-down of the LOCK-IT-100 trial, despite an increase in CMC-related expense. SG&A expense increased approximately 18% compared with the first half of last year.

Higher staffing expenses, legal and consulting fees and compliance costs were recorded during the period with declines in patent and investor relations expenses.

Cash used in operations during the first half of 2019 was approximately $7.2 million compared with cash used of $11.4 million in the first half of 2018. The reduction in cash used in operations occurred mainly as a result of lower operating expenses throughout the first half of the year and the receipt of cash for the sale of the New Jersey NOLs.

As a result of lower operating expenses during the second quarter plus the cash received from the NOL sale, we reported $26.4 million in cash and short-term investments at June 30, almost the same amount as we had on our balance sheet at March 31, 2019. Based on our existing cash and short-term investments at June 30, we believe we have the funds necessary to continue our operations, including the submission of the Neutrolin NDA and initial preparations for a commercial launch into the third quarter of next year.

The timing and amounts of any future capital raised by the company will be driven by the anticipated timing of the NDA approval and by the strategy we adopt with respect to Neutrolin's commercialization in the U.S. market. We expect to implement a commercialization plan designed to successfully realize Neutrolin's commercial value and thereby, optimize shareholder returns.

With that, I will now hand the call back to Khoso for his closing remarks. Khoso?


Khoso Baluch, CorMedix, Inc. - CEO & Director [8]


Thank you, Bob. What Phoebe, Jack and Bob covered with you, hopefully provides you insight into the work effort on which we have focused that have occurred over the last 3 months. I'm pleased about the progress we are making and like to reemphasize we're extremely pleased to report to our shareholders that the major corporate objective this management team undertook in 2017 to successfully complete LOCK-IT-100 and provide the clinical data required to support a marketing application for Neutrolin in the U.S. has been met.

As Phoebe elaborated, the progress with the FDA has been tremendous. The high-quality work the team invested in the project has paid off. The team is now focused in parallel on the upcoming FDA meetings and the continuing preparation of the NDA components.

Jack discussed the company's current effort on both the CMC and supply chain work for the U.S. market, and Bob provided insight into the current balance sheet and cash flow. If approved, we believe Neutrolin will become the standard of care for preventing catheter-related bloodstream infections in the population of CBC users.

I'm very pleased with the strength of our management team and we will continue to evolve by augmenting our team over the coming quarters in areas of strategic need. I'm also confident that the strategy we embarked on in early 2017 will continue to move study works forward at an ever-increasing pace. I look forward to providing you with material development and updates via our CorMedix website, press release and conference calls.

Thank you for your continued support of CorMedix. And now I'll hand this back to the operator.


Questions and Answers


Operator [1]


(Operator Instructions) Our first question comes from Ram Selvaraju of H.C. Wainwright.


Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]


So I just wanted to know if you could elaborate at this juncture regarding the environments for Neutrolin, particularly as this pertains to 3 important aspects. Firstly, the pricing framework, especially as this pertains to the transitional drug add-on payment, or TDAPA, which I believe you talked about previously, but I wanted to ascertain what you think are potentially the principal impacts or key takeaways from CMS-proposed changes to the TDAPA framework?

Secondly, if you could talk perhaps about the specific CMS codes that might be applicable to Neutrolin and in particular, what positive impact there may be from CMS' decision to shift to a quarterly J-code assignation schedule?

And lastly, if you could perhaps talk about the category of drug that Neutrolin would be most likely to fall into? And what this could potentially mean from the perspective of formulary positioning and the broader reimbursement access beyond the Medicare and Medicaid context?


Khoso Baluch, CorMedix, Inc. - CEO & Director [3]


Thanks, Ram, for your questions. Let me take a stab in answering it. So in terms of the pricing framework, I think the way things stand right now is very good. TDAPA has tried to narrow the focus that they have got in where they would allow products to be outside of the bundle, clearly to products that bring innovation to the marketplace. A new chemical entity clearly fits into that and Neutrolin will obviously benefit out of it.

In terms of doing the review, the J-code that you had requested on a quarterly basis than what they were doing previously, actually, is a benefit because you do need to get these codes and more frequent addition of these codes, depending on we will get your approval, helps newer products that come to the market get these J-Codes faster than what would have happened normally because you may have missed the deadline and have to wait a long period before you get it.

In terms of formulary, it's a bit early right now to comment on it. Clearly, in terms of catheter-lock solutions, the only catheter-lock solution that is used out there is heparin. What we have seen from our data and our market research that we have done, we would clearly be a significant improvement to what -- heparin is in the marketplace and therefore, we will be working with the formularies to get Neutrolin on to the formularies as soon as possible.


Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [4]


Great. And just very quickly a follow-up if I may. Regarding the NDA filing process, can you give us a sense, just refresh my memory as to whether this is going to be a modular filing process, how many modules we expect there to be? And what kind of timing interval there would be with respect to the submission of the different model -- modules under the rolling submission?


Phoebe Mounts, CorMedix, Inc. - Executive VP & General Counsel [5]


Thank you for the question, that's very insightful. You clearly understand some of the issues that need to be addressed with FDA at the pre-NDA meeting. So there are a lot of administrative details that need to be addressed, and you've pointed out the option of a rolling submission. As I noted in my comments during the call, we have received fast-track designation from FDA that makes us eligible to request rolling submission from FDA. And so if that request is granted, then we will be in a position to select specific modules and sequence for submission to FDA and that's part of the negotiation.

As I'm sure a lot of you are aware, part of the challenge for the CMC package is to have preapproval inspection scheduled and completed by FDA during the review process so there's clearly advantages in having the CMC section go in first. So those preapproval inspections can be assigned and completed by the agency as fast as possible. The clinical section clearly is very important for the successful review and approval of NDA. So that's another section that may be considered for priority for submission. So certainly, the sequence and the timing of the submissions of the module will be discussed with FDA and negotiated and agreed upon at the pre-NDA meeting. Thank you.


Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [6]


So just as a clarification though, the timing of the intervals between the module submissions, I would assume that if the data -- the information is readily available, it wouldn't take more than a few months between the different module submissions, right?


Phoebe Mounts, CorMedix, Inc. - Executive VP & General Counsel [7]


Few months is a long time. We're working very hard to make that much shorter. Thank you. We're doing it as fast as we can and certainly, it will be as efficient a process as we can gather forces to do.


Operator [8]


(Operator Instructions) And ladies and gentlemen, this will conclude our question-and-answer session. I will now turn the conference back over to Khoso Baluch for closing comments.


Khoso Baluch, CorMedix, Inc. - CEO & Director [9]


Thank you very much, and I'd like to thank everyone for attending this call. We really appreciate your support. It's an exciting time for the company as we enter this next phase. The opportunity is there. So I'm -- I have a great team here with us. And clearly, quality is what is going to be very important as we continue to go forward and bring Neutrolin to the market. So thank you very much for all your support. Thank you.


Operator [10]


Thank you. This does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time, and have a great day.