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Edited Transcript of ACRX earnings conference call or presentation 9-Nov-17 9:30pm GMT

Q3 2017 AcelRx Pharmaceuticals Inc Earnings Call

REDWOOD CITY Nov 21, 2017 (Thomson StreetEvents) -- Edited Transcript of AcelRx Pharmaceuticals Inc earnings conference call or presentation Thursday, November 9, 2017 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jane Wright-Mitchell

AcelRx Pharmaceuticals, Inc. - Chief Legal Officer

* Pamela Pierce Palmer

AcelRx Pharmaceuticals, Inc. - Co-Founder, Chief Medical Officer and Director

* Raffi Mark Asadorian

AcelRx Pharmaceuticals, Inc. - CFO

* Vincent J. Angotti

AcelRx Pharmaceuticals, Inc. - CEO & Director

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Conference Call Participants

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* Antonio Eduardo Arce

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

* Ashley Ryu

RBC Capital Markets, LLC, Research Division - Senior Associate

* Michael John Higgins

Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst

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Presentation

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Operator [1]

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Welcome to the AcelRx Third Quarter 2017 Conference Call. This call is being webcast live on the Events page of the Investors section of AcelRx website at acelrx.com.

This call is the property of AcelRx, and any recording, reproduction or transmission of this call without the expressed written consent of AcelRx is strictly prohibited.

As a reminder, today's call is being recorded. You may listen to the webcast replay of this call by going to the Investors section of AcelRx's website.

I would now like to turn the call over to Jane Wright-Mitchell, Chief Legal Officer. Please go ahead.

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Jane Wright-Mitchell, AcelRx Pharmaceuticals, Inc. - Chief Legal Officer [2]

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Thank you for joining us this afternoon. Today, we reported our third quarter 2017 financial results in our press release.

The release and the slide presentation accompanying this call are available on the Investors section of our website.

With me today are Vince Angotti, our Chief Executive Officer; Pam Palmer, our Chief Medical Officer; and Raffi Asadorian, our Chief Financial Officer.

During this call, we will make forward-looking statements about events and circumstances that have not yet occurred, including, but not limited to, the process and timing of anticipated future developments of DSUVIA, known as ARX-04 outside the United States, and ZALVISO; including AcelRx's plans for meeting with the FDA and resubmission of the DSUVIA and ZALVISO NDAs to gain approval in the U.S.; the scientific review and approval of the Marketing Authorization Application with the European Medicines Agency of ARX-04; the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for DSUVIA, ARX-04 and ZALVISO, and the company's ability to continue to cash -- its cash management plan to maintain a solid liquidity position and financial flexibility, and its projected cash flows.

These statements are based on management's current expectations and inherently involve significant risks and uncertainties. Actual results and timing of the events could differ materially from those anticipated in such forward-looking statements. And as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx's product development programs and outcomes of any regulatory reviews; the possibilities that regulatory agencies could dispute or interpret differently the results of AcelRx's clinical trials; the accuracy of AcelRx's estimates regarding expenses, capital requirements and the need for financing; and other risks, including those detailed in the company's recent SEC filings in the Risk Factors section of its quarterly report on Form 10-Q filed on August 2, 2017, and our quarter ended September 30, 2017, Form 10-Q, which was filed earlier today.

AcelRx disclaims any obligation to update information contained in these forward-looking statements, whether as a result of new information, future events or otherwise. Please refer to the AcelRx SEC filings for detailed discussions on the relevant risks and uncertainties.

I'll now turn the call over to Vince Angotti. Vince?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [3]

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Thank you, Jane. Good afternoon, and thank you for joining us today. AcelRx is a company that remains focused on providing physicians and patients with noninvasive pain management options from moderate to severe acute pain within medically supervised settings to the development of 2-key products, DSUVIA and ZALVISO.

In brief, most recently, we reported the receipt of a CRL regarding our DSUVIA NDA. After diligent and thoughtful review of the CRL, in consultation with outside experts, we have submitted our Briefing Book to the FDA requesting a Type A meeting. Pending the FDA's calendar, we expect to have this meeting prior to the end of the year, which should provide clarity on the resubmission pathway.

At the beginning of the third quarter, we announced the completion of the successful Phase III clinical trial for ZALVISO, and we remain on track to resubmit the ZALVISO NDA by year-end, but will do so after we have the DSUVIA Type A FDA meeting.

Throughout the quarter, we prudently managed our cash flow to end the quarter in a solid cash position, providing us with financial flexibility.

Now on the call today, there are main 3 topics we'll cover: one, the DSUVIA CRL and our path to resubmission; two, key milestones for the coming 12 months; and three, highlights the third quarter financial performance and the near-term cash flow outlook.

Starting with Topic 1. Although we were disappointed by the receipt of the DSUVIA CRL, we believe the recommendations presented by the agency are manageable. As a result, we've already taken steps outlining the path towards resubmission. Specifically, the first step towards resubmitting the DSUVIA NDA was the compilation of additional data for the Briefing Book that accompanied the Type A meeting request, which has been submitted to the agency. Our goal is to have this meeting before the end of the year. Again, the outcome of the Type A meeting should provide more clarity on the DSUVIA NDA resubmission pathway.

As a reminder, the 2 primary recommendations within the CRL were: first, while the FDA commented that the safety database was suitable in number of patients, the collection of additional data was requested on at least 50 patients to assess the safety of DSUVIA towards the maximum amount described in the proposed label; and second, to ensure proper administration of the tablet with the single-dose applicator for FDA. The FDA recommended certain changes to the directions for use to be validated through a human factor study.

With regard to the FDA's recommendation to further ensure proper administration of the DSUVIA tablets with the FDA, we have included in the Briefing Book proposed modifications to the directions for use and also proposed a human factor study protocol to validate these modifications. We hope to receive confirmation from the FDA during the Type A meeting that these changes address the recommendations in the CRL.

Now to address the topic of maximum dosing, we've gathered adverse event in sufentanil plasma concentration data from patients exposed to high cumulative doses of sufentanil sublingual tablets including those beyond the theoretical maximum DSUVIA daily dosage. As a reminder, DSUVIA is a prn, or an as-needed medication. And a proposed DSUVIA label states that a single tablet is not to be dosed more frequently than once every 60 minutes for a maximum available dose of 24 tablets in 24 hours. This additional data, in conjunction with previously submitted data, will be discussed with the agency as it relates to the recommendation in the CRL.

In addition, we've been attending conferences in the past several months with presentations of DSUVIA-related clinical data. At the recent Anesthesiology 2017 Conference Symposium entitled Frontiers in Opioid Pharmacotherapy, we presented data regarding the favorable tolerability profile of DSUVIA where the most common adverse events were nausea, headache and vomiting. The pooled efficacy and safety analysis of our DSUVIA clinical trials was recognized as a top abstract.

Now moving on to our second topic regarding anticipated highlights for the upcoming 12 months. There are a number of key regulatory milestones and catalysts, the timing of which for the U.S. are largely dependent upon the recommendations and information received from the Type A FDA meeting, which is our first milestone. As previously stated, depending upon the FDA calendar, we anticipate this meeting will take place sometime around the end of this year.

The second milestone is the potential resubmission of the DSUVIA and ZALVISO NDAs; the 3rd, potential DSUVIA and ZALVISO Advisory Committee meetings; and fourth, potential PDUFA dates for DSUVIA and ZALVISO.

Beyond the U.S. milestones, a CHMP opinion for ARX-04 for which EMA has recently accepted the name DZUVEO, spelled D-Z-U-V-E-O for Europe, is expected in the first half of 2018.

Our immediate focus is on DSUVIA in the U.S. and getting the NDA back on file. We'll continue to concentrate on this in the near term. We'll provide an update on timing after we receive more clarity from the FDA.

And finally as a reminder, ZALVISO is already approved in Europe, and I want to highlight its recent performance. Our partner in Europe, Grunenthal, continues to see increases in ZALVISO product demand with their enhanced focus on penetration into existing possible customers, thus yielding continued patient growth. And we estimate close to 16,000 patient exposures of ZALVISO through the end of 2017.

Clinical -- commercial launch has also been instrumental in allowing us to better understand our approach to commercial targeting and the go-to-market strategy for the U.S.

Now let me turn the call over to Raffi for our third topic, a review of our financial results and near-term cash flow outlook.

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Raffi Mark Asadorian, AcelRx Pharmaceuticals, Inc. - CFO [4]

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Thanks, Vince, and good afternoon, everyone. The third quarter, much like the previous quarter, was managed conservatively from a financial perspective as we did not ramp up commercial resources prior to the PDUFA date for DSUVIA. We will continue to manage our cash prudently to ensure we have adequate financial resources as we focus on obtaining approval for our 2 product candidates.

Moving on to the third quarter results. Q3 2017 revenues were $1.5 million, which primarily consisted of ZALVISO product sales to Grunenthal. The total revenue decline of $1.9 million from Q3 2016 was attributed mainly to lower invoicing under our DSUVIA contract with the Department of Defense due to a lower amount of DSUVIA development-related work in the quarter.

We have recognized a total of $16.1 million in revenue under the current $17 million contract with the Department of Defense. We ended the third quarter with $67.9 million in cash and cash equivalents, which was an increase of $5.8 million over the second quarter of 2017. The increase was mainly driven by the use of our ATM facility to raise $13.1 million net of fees during the third quarter. We set out an objective to raise additional capital to ensure we ended the quarter with at least $65 million in cash, which we believe will provide us a solid quarter-end liquidity position.

Excluding the net proceeds from the ATM stock sales, the net cash outflow during the quarter was $7.3 million, which was lower than both the first and 2nd quarters of this year. This was mainly driven by our operating expenses, or combined G&A and R&D expenses, which, net of stock-based compensation, were $7.4 million in the third quarter 2017, declining from $8.1 million in the second quarter of 2017 and $7.8 million in the third quarter of 2016. The declines were attributed to lower ZALVISO-related development costs incurred in Q2 2017 and DSUVIA Phase III trial costs in Q3 2016.

Operating expenses were the main driver of our cash flows and will continue to be in the near term, particularly given a significant portion of European ZALVISO royalties and milestones were already monetized with PDL in 2015.

Debt service in the third quarter was approximately $0.5 million, which will increase in the coming quarters as our loan begins to amortize.

Looking forward, we expect our quarterly pre-commercialization net cash burn to be in the $10 million to $11 million range, depending upon the quarter, which includes anticipated costs related to certain regulatory activities and some prelaunch preparation costs. The planned uptick from the third quarter is mainly due to the approximate $2 million of quarterly debt service in 2018, but approximately $4 million in the fourth quarter of 2017 due to the payment of the deferred fee to Hercules made in October.

We will provide further cash flow guidance as needed upon obtaining clarity from the FDA on the timing of potential resubmission and approval.

With that, let me turn the call back to Vince.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [5]

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Thanks, Raffi. Just to summarize, and our immediate focus is on the request of Type A meeting with the FDA, which we anticipate will be held before the end of the year. We believe we will have a clear path towards resubmission of the DSUVIA NDA after consultation with the FDA.

Finally, we'll continue to be prudent with our cash. We'll await further regulatory clarity before expanding our commercial or other resources.

Now I'd like to open the line for any questions you may have. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Randall Stanicky with RBC Capital Markets.

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Ashley Ryu, RBC Capital Markets, LLC, Research Division - Senior Associate [2]

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This is Ashley Ryu, on for Randall. I have 2; so first, on the DSUVIA CRL. I want to clarify exactly when you submitted your request for the Type A meeting. And when do you expect to provide an update or in the path forward? Would it be following the receipt of meeting minutes? And if so, would you expect us to have that update kind of before the end of the year? I also saw that you intend to resubmit the NDA for ZALVISO after the Type A meeting for DSUVIA. I understand that this doesn't necessarily imply any change in timing since you had always said that you intend to submit it before year-end, but just want to understand why you wanted to wait until after the meeting for DSUVIA, since presumably the issue with DSUVIA doesn't have any readthrough for ZALVISO.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [3]

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Yes, let me see if I can just tackle those questions quickly. So I think the first one was when did we submit the Type A meeting request for the DSUVIA CRL. So that would have occurred for this week. So -- and we've got confirmation of receipt on it this week.

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Ashley Ryu, RBC Capital Markets, LLC, Research Division - Senior Associate [4]

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Okay. And then, would we receive an update following DSUVIA's meeting minutes?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [5]

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Yes. That would be most likely, simply because at that point, you've got confirmation of what was discussed in the meeting and would be dependable information moving forward as it's been documented. I think the final question you had was ZALVISO after the Type A meeting. Yes, let me just be clear. We prepared the resubmission of the ZALVISO NDA. So we continue to stay focused on that track moving forward, but decided to hold on this until after our Type A FDA meeting, regardless of DSUVIA, just to be sure we have all available information before resubmitting. And while there isn't clearly a readthrough from the ZALVISO CRL to DSUVIA CRL, we think it's wise because of the common platform with sublingual sufentanil tablet to be sure we understand everything we can before submitting that -- or resubmitting that NDA.

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Operator [6]

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Our next question comes from [Roger Song] with Jefferies.

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Unidentified Analyst, [7]

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So I have 3 questions here. The first one is, Vince, can you comment to what extent has the political environment today contributed to the decision on DSUVIA? We know recently President Trump just declared a national emergency on opioids and the doctor colleague always the first initiative is combating opioids crisis.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [8]

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Sure. So clearly, we're well aware of the political environment around the opioid epidemic in the U.S. And you would ask, do we feel that affected the decision for DSUVIA? We can't comment as it relates to the FDA's perspective from that political environment and the opioid epidemic in the U.S. and whether that was directly relevant to the decision of commentary we received on DSUVIA. We believe the commentary was, again, focused on the scientific material that was supplied to them. As it relates to us, in particular, our position as it relates to our development programs has not changed, and that's why we're addressing in the development programs moderate-to-severe acute pain in a medically supervised setting. That's where our limitations stand. We have no interest in our products moving forward as it relates to the retail outlet that you might expect to typically see some of these opioids, in whether it'd be your local chain like a CVS, Walmart or Kroger. To that end, we also have no interest in growing the opioid market as it relates to our products. In the event that the medical professional under medical supervision has decided that the opioid is the proper class of medicine to address these moderate-to-severe acute pain patients in that hospital-type setting, we've got a compelling alternative moving forward once that decision has already been made. I hope that helps answer the question, [Roger].

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Unidentified Analyst, [9]

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Yes, it's helpful. Thank you for that clarification. So the next question is, so during the FDA, NDA review, how far have you entering to the label claim discussion regarding the DSUVIA with FDA?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [10]

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So as it relates to that question, we won't comment on how far it's difficult to give a measurement. What I can comment to you is that the components within the CRL were not issues that we had discussed along the way.

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Unidentified Analyst, [11]

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Okay, sure. So last question. So regarding the human factor study, so you said you already requested the Type A meeting and you consulted the external consultant. So could you provide some kind of comment on the strategy, how would you address this human factor study?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [12]

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So as it relates to the human factor study, the strategy will not be that different than what we had done before, other than the fact that making additional modification to the directions for use and conducting the study historically as we have for DSUVIA. And just to give you some history of perspective, when we conducted this study for DSUVIA before, it was in the neighborhood of about 45 participants and took less than a month to complete.

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Operator [13]

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(Operator Instructions) And our next question comes from Michael Higgins with Roth Capital Partners.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [14]

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If I understand you right, you believe the safety of in a certain unspecified number of patients when taking DSUVIA, let's say, once per hour or at least near that match. Is that -- I guess, that's the first half of the question, if you can comment on that. The second half being, is there potential to file or to seek approval with a slightly different label rather than run the 50-patient study?

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Pamela Pierce Palmer, AcelRx Pharmaceuticals, Inc. - Co-Founder, Chief Medical Officer and Director [15]

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Sure, Michael. it's Pam. Yes, we believe that we have sufficient number of patients to address the dosing in the maximal range for DSUVIA. And regarding the label, I mean, we would expect that information to come out of the meeting. We'll have more clarity that post-CRL meeting with the FDA and upon resubmission. Certainly, we'll make it into detailed label negotiations. We'll be talking about that.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [16]

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Michael, you're asking specifically as it relates to the dosing in the label or something other than that when you comment on a separate different label?

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [17]

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Yes, that was from my second question, but I'll try to bond them here and kind of get a sense for how adherent you are to keeping the proposed labeling as it is. And there's a number of ways that could be changed. One of which is, instead of the prn, it could be every 2 hours. Eventually, you could change this by age, which is not uncommon with opioids. And there's other factors as well that could certainly adjust what you're going for, rather than run that 50-patient study. So I'm just trying to assess how tightly you're hanging on to your proposed labeling so far.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [18]

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Yes, good questions. Pam can continue to answer those.

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Pamela Pierce Palmer, AcelRx Pharmaceuticals, Inc. - Co-Founder, Chief Medical Officer and Director [19]

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Sure. And I mean, I think we have -- had folks ask us about that. I mean, is there simply a way to change the label? One thing to keep in mind when you talk about changing it every 2 hours or something like that, we ran our efficacy studies while allowing 60 minutes in between dosing. So you don't want to invalidate any of your efficacy studies. Also, we don't have any safety concerns with the dosing of our drug, and so the question is whether you'd in fact limit the dosing for product when there is no safety signal dictating that limitation. These are all questions and discussions we will have with the FDA, but we do believe that we have sufficient data from the enrollment in both our DSUVIA and ZALVISO studies that bracket that maximum allowable dosing. And we believe we've got sufficient safety, both in an adverse event profile and plasma concentration levels of sufentanil that we have submitted to the FDA.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [20]

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So if I hear you the right, it sounds like you don't see a problem with your safety profile even when dosed every hour. The FDA would like to see more patients, more higher-end than what you've got and we're not sure what you have, but certainly it sounds like it's not enough to satisfy the FDA. So they will just simply look for more information than what you have. And it doesn't sound like you find any need to change your label because what you're looking at is demonstrating enough safety. Is that a fair summary?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [21]

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Well, yes. We -- so we have submitted additional data, additional patients, and to give us that sufficient database at that higher dosing amount. And we feel that is supportive of our label, but we will have discussions with the FDA regarding the specific wording of the label.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [22]

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Yes, I think it's important to understand that they have data from the original NDA that's been reanalyzed within our submission of the recent book as well as new data that they had not previously had. So with that being said, I think that needs to be in a consideration, and that's what we'll discuss with them moving forward.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [23]

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One last one before I jump back in the queue. Any pushback by age from the agency in the discussions with that?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [24]

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Pushback by age?

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [25]

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Oh, dosing by age. Any differences during an adverse event by age.

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Pamela Pierce Palmer, AcelRx Pharmaceuticals, Inc. - Co-Founder, Chief Medical Officer and Director [26]

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No, we've analyzed, as one has to do for the integrated summary of safety in the NDA, by different subgroups. And we feel very confident in our safety for the number of different subgroups, whether it's gender, age, BMI, et cetera.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [27]

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And I will reiterate the comment I think we've earlier in that the FDA did state to us in the CRL that the number of patients in the safety database was sufficient moving forward with this particular dose that they had a question about.

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Operator [28]

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And our next question comes from Ed Arce with H.C. Wainwright & Co.

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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [29]

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Apologies if this already had been addressed. I joined a bit late. But wondering if there's been a date set for you to meet with the agency; and if not, when would you expect to do so? And then, also, if a study is ultimately deemed necessary, about how long do you think ultimately the delay could be before you could refile?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [30]

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Thanks, Ed. So I'll aim the first portion and Pamela will handle the second portion. So we did comment earlier that we did submit the request of the Type A meeting and accompanying briefing this week. A date has not been set, but we did receive confirmation from the FDA that they received the materials. Typically, the guidelines or that they would provide a meeting to you based off the receipt of that request within 30 days. Clearly, that's our hope and goal, but it will depend on the FDA's calendar. As it relates to the second, in the study, I'll refer that one to Pam.

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Pamela Pierce Palmer, AcelRx Pharmaceuticals, Inc. - Co-Founder, Chief Medical Officer and Director [31]

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Sure. We can't really speculate on the study design, what that study would look like, how long it would take. It would be an extremely difficult study to even conduct, given the nature of pair and dosing of this drug. And again, to reiterate, they did say that our safety database was suitable in number. So it's not clear that there's actually additional clinical study that is required. So we just feel very positive about the new analysis and the new patients that we've put together and were willing to put into a new resubmission of the NDA.

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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [32]

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Okay, and perhaps one follow-up. If you, perhaps, could summarize the objective -- your objectives of the meeting with the FDA into maybe 2 or 3 key things. What would be the optimal outcome you think of that meeting?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [33]

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Yes. So we don't want to speak for the FDA and, again, to communicate things before we have a discussion with them. But clearly, and we said it I think a number of times here, we believe the data that we've submitted to them, both the reanalysis of data on hand as well as new data, could potentially satisfy the request for the item in CRL: number one, that leads to maximal dosing; number two, we believe the human factor study is one we can execute well and have a history of doing that as it relates to DSUVIA. And so, finally getting a clear path that is concrete and measurable moving forward. So that in collaboration with the FDA, we actually have agreement on those next steps, as opposed to a neutral area.

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Operator [34]

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We have time for one more question, and that's a follow-up from Michael Higgins with Roth Capital Partners.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [35]

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Just want to follow up regarding the human factor study in the dropped tablets. If the instructions were to state that the health care professional needed to stay in the room while the patient has that NanoTab under the tongue, would that satisfy what the FDA is looking for?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [36]

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Well, I can comment to you, that wasn't one of the suggestions they had communicated. The clear objectives...

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [37]

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(inaudible) like instructions.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [38]

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Yes. Now the in tangent into that, the goal is to be sure that you observe the pill in of the sublingual space, so to confirm observation. And that would be the closest to it.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [39]

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And that's already the instructions for you. So that's in addition to, sir?

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [40]

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So without getting to too many of the specifics as it relates to that, it's highlighted more in a more pronounced fashion.

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [41]

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Got it. Very helpful.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [42]

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Does that help, Mike?

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Michael John Higgins, Roth Capital Partners, LLC, Research Division - MD & Senior Research Analyst [43]

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Very much.

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Operator [44]

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And this concludes our question-and-answer session. And I'd like to turn the conference back over to Vince Angotti for any closing remarks.

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Vincent J. Angotti, AcelRx Pharmaceuticals, Inc. - CEO & Director [45]

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Thanks, Steven. And thank you for joining us today and for your continued support of AcelRx. We look forward to updating you on the continued progress of the regulatory path forward and the outcomes in the coming months; and we're confident in our approach. We look forward to our meeting with the FDA. Thank you, and have a great day.

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Operator [46]

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The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.