Acorda Therapeutics Inc (ACOR) 2009 Q2 法說會逐字稿

Thank you for holding. Welcome to the Acorda Therapeutics second quarter 2009 financial results conference call. At this time, all participants are in a listen-only mode. There will be a question and answer session to follow.

Please be advised that this call is being taped at the company's request. Now, I would like to introduce your host for today's call, Tierney Saccavino, Vice President, Corporate Communications at Acorda Therapeutics. Please go ahead.

Good morning everyone and welcome. With me today are Dr. Ron Cohen, our President and Chief Executive Officer, and David Lawrence, our Chief Financial Officer.

Before we begin, let me remind you that this presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts regarding management's expectations, beliefs, goals, plans or prospects, should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain, FDA approval of Fampridine-SR, the risks of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR if approved, and Zanaflex Capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics operations and unfavorable results from its pre-clinical programs.

These, and other risks, are described in greater detail in Acorda Therapeutics filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this presentation.

I'll now turn the call over to our CEO, Ron Cohen.

Thanks, Tierney. Good morning, everyone. Welcome. This morning we reported our second quarter 2009 financial results. I'm going to provide a brief review of the key milestones from the second quarter and then I'll turn the call over to Dave, who will provide a financial summary, and we'll then open the call for questions.

In the first quarter of 2009, we initiated a process to evaluate partnership opportunities for Fampridine-SR in markets outside the US. There was a high level of interest and we're very pleased that the process resulted in a partnership with Biogen Idec. Biogen Idec is one of the world's leaders in developing and marketing MS products and we believe that they are ideally suited to maximize the value of Fampridine-SR in ex-US markets if it is approved, which could deliver significant long-term value to our shareholders.

Biogen Idec will be responsible for the regulatory and commercialization activities for all ex-US territories, which will take advantage of their experience and success in those markets and will also allow us to focus our attention on preparing for launch of Fampridine-SR in the US, if approved.

As we noted in our last earnings call, the FDA has accepted the Fampridine-SR NDA for review, with a PDUFA, or action date, of October 22nd. As expected, we've been notified by the Agency that an advisory committee meeting will be held for Fampridine-SR. The FDA will announce the date of the meeting in the Federal Register.

We announced updated retention rates in our extension studies for Fampridine-SR in the press release this morning, with 82% of patients continuing in the 204 extension trial, after up to almost two years, 66.9% of patients in the 203 extension, after up to three-and-a-half years, and 47% of participants in the 202 extension, after up to over five years.

Data from the extension studies will be presented at two upcoming medical meetings in Europe, a platform presentation at the European Committee on Treatment and Research in Multiple Sclerosis, or ECTRIMS, on September 10th in Dusseldorf, Germany and at the Congress of the European Federation of Neurological Societies, being held September 12-15, in Florence, Italy. In addition, data from the Fampridine-SR thorough QT studies will be presented at the ECTRIMS meeting.

In today's release, we also provided an updated adverse event table. Previously, we presented combined safety data from our Phase III MS studies, but since both the proposed Fampridine-SR label and the advisory committee presentation will likely comprise integrated safety data from all three controlled studies, MSF202, 203, and 204, we've updated the table with adverse event terms standardized across all studies.

As a result, percentages reported in earlier tables have changed slightly, which in some cases affects their rank order. The only new AE that now reports at over 5% is MS relapse, at 5.3% for the Fampridine-SR treated group, and 3.8% for placebo. The imbalance between treatment groups for this event was due to worsening of MS symptoms occurring after discontinuation of drug.

Turning to our Zanaflex franchise, gross sales in the second quarter were $14.8 million, up approximately 12.6% from the second quarter of 2008. Total shipments were 16.6 million. We have seen a recent slight decrease in both new and total prescriptions over the last two quarters. We believe it is too soon to tell whether this represents a longer term trend as the franchise matures, or a short-term aberration, possibly due to recent economic conditions.

Now, I'll turn the call over to Dave for review of the financials.

Thanks, Ron. For the second quarter ended June 30, 2009, the company reported a net loss of $23.3 million, or $0.62 per diluted common share, compared to a net loss of $18.8 million, or $0.58 per diluted common share for the same quarter in 2008.

Included in the second quarter 2009, we recorded a license revenue receivable and deferred revenue of $110 million for the up-front payment related to our collaboration and license agreement with Biogen.

We also recorded $7.7 million as license revenue payable and deferred expense recorded in other assests for the 7% payment due to Elan as required by our existing license agreement with Elan. Given the multiple components of the contract, we are currently assessing the accounting implications of these transactions.

Total operating expenses for the quarter ended June 30th, 2009, were $31.8 million compared to total operating expenses of $25.6 million for the same quarter last year. Research and development expenses were $7.9 million for the second quarter 2009, which includes costs related to our Fampridine-SR long-term extension studies, costs related to our NDA for Fampridine-SR, and continued development of our pre-clinical pipeline products, for a potential IND filing in late 2009.

R&D costs were $8.1 million for the same quarter in 2008. This decrease in R&D costs, quarter over quarter, is primarily due to a decrease in expense associated with the conclusion of our Phase III clinical trial of Fampridine-SR in 2008, partially offset by an increase in expense related to work on our pre-clinical pipeline products.

Sales, general, and administrative expenses for the quarter ended June 30th, 2009 were $23.9 million, compared to SG&A expenses of $17.6 million for the same quarter in 2008. This increase of $6.3 million is due to an increase in disease state awareness programs and other pre-launch activities associated with the commercialization of Fampridine-SR, if approved.

Also contributing to the increase in expenses are sales and general administrative staff and other costs related to supporting the growth of the organization, and increases in business development costs related to our collaboration and licensing efforts.

Other net expense for the quarter ended June 30th, 2009, included $368,000 in interest income from our cash investment activities, offset by $1.5 million in interest expense, due to the Paul Capital Healthcare agreement.

As of June 30th, 2009, Acorda held cash, cash equivalents and short-term investments of $212.4 million. We expect this balance, in addition to the net proceeds of $102.3 million from the Biogen collaboration agreement, will provide us with a year-end cash, cash equivalents and short-term investment balance in excess of $250 million.

Now I'll open the call to questions. Operator?

At this time we will take any questions you may have. (Operator instructions.) The first question comes from the line of Michael Yee, RBC Capital Markets. Please go ahead.

Thanks, Ron. Good morning. Two questions for you. When Biogen signed the deal, is it safe to assume they had access to all the open label safety studies that are getting presented next month?

And then on the MS relapse, how was that specifically defined in the trial? Was that -- could it be someone who is benefiting then comes off, and then they don't have a benefit from the drug so they think that's the disease worsening? Or was that an actual neurological relapse or help us understand how that may have been defined.

Okay, I think there may be two questions in there, Michael. The first one about Biogen, could you repeat that so I'm sure what (inaudible - multiple speakers) you are asking?

Just in terms of diligence, is it safe to assume they had access to all the open label safety studies, including what's being presented next month?

You mean, did Biogen have access to all those data? Yes.

Okay.

And then on relapse, relapse is a clinical judgment on the part of each investigator. There is no predefined term, and in fact, the terms that wind up getting coded into the term MS relapse are various. So, sometimes they can be listed as an MS exacerbation, or aggravation reaction, or sometimes they just say MS, or worsening of MS symptoms. Sometimes MS relapse.

And all of that gets coded to the term MS relapse by convention in the MedRA dictionary. So it can encompass a variety of things, anything from what people think of as a "true relapse" with, for example, a new neurological symptom based on a new inflammatory lesion, to a worsening of a particular symptom, either walking less, or getting weaker, or so on. So it's a wide range.

Okay. All right. I'll leave it there, thanks.

The next question comes from the line of David Amsellem, Piper Jaffray. Please proceed.

Hi, thanks. I wanted to ask a couple of questions on commercialization. Can you talk about your dialogue with managed care organizations? And do you believe it's reasonable to expect that Fampridine will eventually have unrestricted access on most plans?

Well, I can't really speculate on any of that, David. We are in active discussions with managed care. We are continuing a vigorous research, or pricing research program, so that by the time we get to hopefully approval, we have solid ground on that.

We also have to wait for the final label, so that we can cement, or firmly establish, what the price will be and also what the nature of the contracting might be. So, at this point, I can't give you any specifics except to say that we are fully engaged on all fronts on managed care and reimbursement.

Okay. And then as a quick follow- up on-- patients on compounded 4-AP, are you planning any co-pay assistance programs to incentivize those patients and doctors to move to the commercially available product? And in general, how do you think about driving the pool of compounded 4-AP patients to the commercially available product after the launch?

Yes, well-- you know, I can't discuss any specific plans or programs in that regard. I will say that our view of the compounding activity is that the vast majority, at least, of people taking it should switch readily to an approved labeled CGMP-manufactured product versus what they're taking now, which is entirely unreliable, not labeled not quality controlled, and for which there have been a number of reports in the literature of quite serious mistakes.

So, you know, on that basis alone, we feel that there is really a natural drive to switching to the approved drug, when it's approved.

Okay and then just one last question, if I may. For the presentation next month of the extension data, is it safe to assume we're going to see an update on serious adverse events from the extension phases of the studies?

Yes. Yes, we will be presenting both safety and efficacy data from the extension studies.

All right. Thanks.

We have a question from the line of Geoff Meacham, JPMorgan.

Hey guys. Thanks for taking the question.

Sure.

Question for you on duration therapy in the extension studies. How does your duration of therapy compared to the use of 4-AP today, based on your market research?

When you say duration, you mean in a given day on one dose, or you mean sort of months or years?

Treatment duration, yes, in months or years.

And you're asking how does that compare to what, Geoff?

To the use of 4-AP today. How does the data in your extension study compare to 4-AP?

I'm not-- compare on-- I'm sorry, let me just try to clarify. Compare in what respect?

I want to get a sense for if the sustained release formulation or if your drug is leading to longer duration of therapy versus what's commercially available today by competitive (inaudible).

Oh okay. So first, I think it's important to distinguish, technically Fampridine is not commercially available today. What it is, is it's compounded by usually local pharmacies, and then dispensed. In other words, it's made by an individual pharmacist, and dispensed with a doctor's prescription for a particular patient.

So it's a cottage industry, if you will, and it is not FDA-sanctioned at all. We really don't have-- it's an apples to oranges comparison. We really don't have data on -- well, on persistence, or quality, or quality of the effect in patients on taking the compounded drug. And that's, in fact, part of the issue, is that it's a completely unregulated activity. There are no studies, there are no-- there's no data available on that. So, we have our data which shows, you know, as we mentioned today, a pretty healthy maintenance of patients at this point, up to over five years on drug in our extension studies, but there is not comparable data available for the compounded drug.

Got you. Okay. And then a follow-up for you just on the adverse events in the extension study. Have you updated data for seizures, and have you seen anything different than what you observed in your randomized trials?

Yes. We have not updated the data. What we've said in the past is that the rate of seizure that we see in the ongoing studies does not exceed the rate that one expects naturally in an MS population, the rate of first seizure, or the rate that was seen in placebo groups from longer term double-blind MS studies, such as for the beta interferons.

Got you. Okay. And then a final question. The adverse event table here, is this pretty much what you guys have culled together in preparation for your extension study data, or will this be updated again?

This is the updated table of most frequent adverse events for the 202, 203, 204 studies. The NDA, obviously, contains data on something well over 1,500 patients from a variety of studies. But these are the core studies, the core double-blind, adequate well controlled studies, on which most of the efficacy cases based on where the comparable safety data, much of the comparable safety data comes from.

So, I don't anticipate that we would update this table again. The reason we updated it now is to include the 202 study, and also the integration of all the terms across all studies so that it more closely, well not more closely, so that it comported to what we expect will be presented at the Ad Comm and also for the proposed label.

Got you. Okay. Thanks.

We have a question from the line of Joel Sendek, Lazard Capital Markets. Please proceed.

Hi. Thanks. So, I have another question on the MS relapse adverse event. Given the fact that it's occur- -- or the difference is occurring after the discontinuation, could you call this AE not drug-related?

Well, you know, it depends on how you get into technical terms. What we can say is that the imbalance is due to worsening of MS symptoms after they come off drug. That's the best we can say, really, on a technical basis.

Is another-- could someone characterize that as a rebound of MS or is there any way to correlate it like that?

It's probably more, more likely to call it a, I would say, a discontinuation response, or an effect of discontinuation, as opposed to rebound in particular.

Okay. I guess what I'm trying to get to is, matching that up with the extension studies. You know, why, maybe a somewhat related question maybe would be, and obviously these people on the extension studies are on for a very long time. But still, they eventually come off. Do you have any clue as to what are the main reasons why people eventually come off drug, once they're on the extension studies?

Yes, it's quite conventional when looking really at any product that's in long-term extension studies. Some of them come off for perceived lack of benefit. Some of them come off for adverse events. And some of them come off for a broad category called other, which is things like loss to follow up or they don't come back for their visits. Or maybe they're MS has progressed to the point where the physician no longer feels they should be on a study. Things like that.

Okay. And then my final question, just regarding the Biogen relationship. I'm wondering if you could just qualitatively tell us how that's gone so far and I'm curious as to whether they're going to be able to, or if they're helping you at all prepare for the FDA Ad Comm meeting?

The relationship-- well it's early days, but it's going great. We are in the early stages of exchanging information and discussing our plans and moving things forward. In terms of the Ad Comm prep, that's really our responsibility. So we wouldn't expect them to be a material part of that.

Okay. Great. Thanks a lot.

We have a question from the line of Phil Nadeau, Cowen and Company. Please go ahead.

Good morning. Thanks for taking my questions. First, a couple on the Ad Comm meeting. Ron, I know it officially hasn't been scheduled yet, but there is an Ad Comm in late September that would seem to fit well with your PDUFA date that, as far as I know, has no drugs associated with it. Is that the most likely time for the Fampridine meeting?

You know, Phil, we can't speculate at all on the FDA's timetable. What they've alerted us to is that we will have an Ad Comm, which is what we had expected. And they've also alerted us that they will post it in the Federal Registry when they have finalized the date.

Okay. And you've mentioned a couple times the preparation for the Ad Comm and tables are likely formats to be presented at the meeting. Has the FDA, in any way, conveyed to you what likely discussion topics are at the meeting?

Well, as a rule -- this is probably a good time to remind everyone -- we never discuss our discussions with the FDA, unless they send us something that we think is material in writing that we need to release. So, we can't really speculate what they're going to cover at the panel meeting. We are preparing for as wide a range of topics as we can think of, and so we're in quite active preparation for the Ad Comm right now.

Okay. And then, a follow up on the MS relapse question. It seems like that would be problematic if , one, it was a statistically significant difference between Fampridine and placebo, and two, it led to an increased rate in disability in the MS patients.

Are either of those true? Is that difference of 5.3% to 3.8% statistically significant? And have you seen any change in the rate of disability in MS patients in the Fampridine group versus the placebo group?

Well, in terms of statistics, we don't run statistics on AE's. It's typically not done. You know, there's no prospective hurdle on that. It's not really a valid way to go, particularly since you have so many AE categories in any given study that if you did apply that standard, some would be statistically significant just by random chance. So that's a tough way to go.

But I will say that most of the people who had these discontinuation worsening of their MS symptoms, wound up going into the extension studies and most of those people are still in the extension studies, and did just fine.

Okay. There's no, as far as you can tell, there's no sign that the rate of disease progression is different on Fampridine versus placebo?

No.

Okay. Great. And last question is on dropouts to date, AE's. Of these AE's, which most prominently lead to drop outs versus which are just maybe more of no consequence?

You know, I think we've actually presented that when we presented data from each of the Phase III trials. I don't have in my head, but there weren't any AE's that stood out, where there was one type of AE that frequently led to dropouts. It was -- we didn't have that many dropouts.

If you recall, I think we had about slightly over 3.5% from the double-blind trials who dropped out because of adverse events and the adverse events were all over the map. It was no one particular type that, or one or two particular types, that led to it. So there was no pattern, in other words. And that's also true in the extension studies. So, people drop out for a variety of reasons, but there's no particular pattern where you can look and say, oh, you know, there's an excess of XYZ adverse events that's causing this.

Okay. Great. Thanks for taking my questions.

We have a question from the line of Mark Schoenbaum, Deutsche Bank. Please go ahead.

Oh hi. I'm sorry, this is Jim Mullins. This is the wrong call. I'm just kidding. Hey Ron, from the double-- I'm confused when I look at the table in the press release. The-- I just want to make sure, is that from only the double-blinded portion of the trial and that does not include extension? Is that correct?

That's right.

And then, and so how are you able to measure what happened after patients came off drug? Can you remind me of the trial design -- were these patients that discontinued early that were having these relapses --

No.

-- or was this at the conclusion of the trial?

Okay. Are you talking about just the relapses, or the-- or all of these AE's?

Just the relapses, sorry.

Okay. And so what's your question?

I'm wondering -- you said that the increase in MS relapses was driven by patients after they came off drug?

Correct.

Was that post the end of the study, or were these patients who were discontinuing drug --

No, no. So-- yes, let's clarify and it's in the slide that, on the WebEx, so you can see it. This table is the most frequent treatment emergent adverse events from the double-blind studies. And it's-- it's similar to the table we've been using all along. The table we've been presenting showed the most frequent treatment emergent events from the 203 and 204 studies combined

This one adds the 202 study and it also codes the terminology in an integrated way, so that all three studies are using exactly the same terminology in exactly the same way, to the extent that it's possible to do so. So that's the only difference.

But, the tables we were using before, and this table, both show the treatment emergent adverse events, which are defined as all the events that occur while on drug in the study and the two weeks after they come off drug in the study. So that's the definition of a treatment emergent adverse event. It includes the 14 days following discontinuation of drug. So that's how we're able to tell.

And do you have any idea if the preponderance of these relapses upon discontinuation were in responders?

No. They were not particularly in responders. It was a mixed bag.

Okay. And did Biogen see this new table prior to signing the deal?

You know, I can't-- first of all I can't get into that kind of specifics --

Okay.

-- in terms of our relationship with Biogen. What I will tell you is, Biogen had access to all of the information and all of the data that we had in the NDA and elsewhere.

Okay. And then final question, Ron, if you don't mind -- have you also recut the old Phase III safety data from the spinal cord injury trials along these same definitions? And is there anything interesting there, if you have?

We-- I don't know about re-cutting. We included all the data in the NDA from the spinal cord injury trials, and there was nothing unexpected there.

Okay. Fair enough. And thanks for being transparent, Ron. Thank you very much.

Thank you, Jim. I'm sorry, Mark.

We have a question from the line from Ram Selvaraju, Hapoalim Securities. Please go ahead.

Hello. Can you hear me?

Yes, Ram.

Okay. A couple of very quick, detail oriented things. So, I would assume that what you are presenting at the meeting in Dusseldorf, and what you're presenting at the meeting in Florence, are essentially going to be the same exact data sets right? There isn't going to be anything different?

Different from what?

Between the two presentations. They are both going to be the same data at these two meetings?

You know what? I have to check that myself. I need to go back and look at abstracts and check it myself. I can't tell you that for sure.

Okay. Ron, with respect to-- I hate to keep coming back to the same topic, but with respect to these MS relapses, obviously this criterion would not apply to those patients who were enrolled in these studies who were classified as having progressive disease, right?

Could you help me with that question a little more? What do (inaudible-multiple speakers) --

Okay. So, you know, those patients who were enrolled in these double-blind studies, you had some patients who were secondary progressive and primary progressive, right?

Correct.

So, those do -- those people do not technically have relapsing, remitting disease? So--

Oh -- no, no. They would be included in that term. Again, that's helpful maybe, to help understand the breadth of this term in the studies. So, in other words, not all of these "MS relapses" were in relapsing, remitting patients. Some of them were in progressive patients.

Okay. And what is specifically deemed relapse after-- I guess, after discontinuation of drug? I mean, is it worsening of existing symptoms or -- ?

Yes, it's all over the map because it's left up to the individual investigator to make the determination. And again, when they do make the determination, they use different terms to describe in a given patient what they're observing. So, they don't necessarily list it in the case report form as MS relapse.

They might list it as exacerbation of MS, or of MS symptoms, or worsening of MS symptoms, or MS. Or sometimes they use something called an aggravation reaction. So the term MS relapse, when we code in these studies to integrate all the terminology to the prescribed terms in the MedRA dictionary, all of those terms I just mentioned wind up being funneled into the one term, MS relapse. Which again, as I mentioned earlier, means that you're covering a very wide swath of observations here. It could be that the patient is not walking as well or fast. It could be that a particular limb got weaker. It could be that their fatigue is worse. It could be that there is a new MS symptom or sign that wasn't seen before. So it's really all over the map.

Okay. And what percentage included in these categories would be classified as severe? None?

I don't have that actually, but it would have been a very small minority of them.

Okay. Okay, and then (inaudible-multiple speakers).

And again, let me say, the difference here is between 5.3% and 3.8%. That difference is accounted for by people who had worsening of MS symptoms when they discontinued the drug. Most of those people, the great majority of those people, then went on and went into the extension studies. They did not drop out. They went into the extension studies. And most of those people who went into the extension studies are still in the extension studies now.

Right. And then just with respect to this term balance disorder, can you just clarify specifically what that means?

No. That's the term that's used. And again, it can cover anything from observing that the patient is having trouble balancing, to dizziness, which also occurs more frequently with drug. This is something that we've seen pretty consistently; however, it does not result in higher falls rate in patients on drug. So you get about an equal rate of falls in placebo and fampridene. You do get these reports of balance disorder that are somewhat more in the fampridene group.

Most of those, the great majority of those, are listed as mild to moderate and transient and people don't drop out as a rule because of that. In fact, that's true of all of these AE's that you see listed here. The great majority of them are listed as mild to moderate. They tend not to persist, and people don't drop out most of the time because of them.

Okay. That's very helpful. Just a very quick thing for Dave, if he's still there? With respect to when the company would have a more clear picture on the accounting implications of the Biogen Idec transaction, can you sort of give us a timeline on that? Can we expect to see more detail on that when you report third-quarter numbers or prior to that?

As soon as we can, Ram, we will provide the detail on the accounting.

Okay. And for the moment, if I assume that the impact to your cash balance would be the net proceeds of $102.3 million, after deducting the payment to Elan, that's probably the most reasonable assumption I can make at this point, right?

That's correct.

Okay. Thank you.

You have a question from the line of Josh Schimmer, Leerink Swann. Please go ahead.

Hey, thanks for taking the questions and sorry to harp on the flare issue but, just as you look at the data, is there anything else you can share that gets you comfortable that the relapse in balance is really just a withdrawal of an active therapy and regression to someone treated baseline, as opposed to any alternative mechanism for recurrence based on reactivation of the inflammatory disease?

We have no evidence for that. The rate of relapse while on drug is the same between the groups. So the excess here is really the worsening of symptoms that some patients got after they discontinued drug.

And that's really all we can say. And again, since we're all repeating ourselves, the vast majority of those patients went on into the extension studies. And they continue in the extension studies. So the wor- -- in other words, the worsening was transient. It did not persist.

Is that something you were able to document, that -- well, was there an actual clinical deterioration? Or it sounds like there wasn't even a documented clinical deterioration, based on your answer to Phil's question.

Yes, most of the time there isn't anything documented, other than the clinicians' or investigators' listing of the either worsening of MS, or MS relapse, or exacerbation of MS, whatever they listed. But yes, so most of the time, you don't have that. But we are able, based on the measures we used in the trial, for many of these patients to show, for example, a transient decrease in walking speed after they come off drug. Not unexpected.

And are you able to document that that decrease normalizes once they're back --

Yes.

-- [into] the extension? Okay. And then with respect to later stage product opportunities for potential acquisition that you mention in the press release, are you able to provide any color on maybe the magnitude of the potential acquisition that you would be considering and/or the timing of such an event?

Can't comment on either one, except to say we would look for products that were meaningful and likely to be meaningfully accretive to shareholder value.

Okay. Great. Thanks for taking the questions.

You have a question from the line of Chris Raymond, Robert W. Baird. Please go ahead.

Yeah. Hi. This is Blake Arnold calling for Chris Raymond. Just two quick follow up questions on the AE data, and sorry to keep going back to this, but could you clarify, did you say that you don't have statistical significance data on the MS relapse rates, and if not, will you upon final data readout or upon presentation to the panel? And then also quickly, could you also clarify, is the panel going to see all the extension study AE data? Thanks.

It's not typical or conventional to run statistical analyses on AE rates. So that was the point I was making earlier. You know, it's not a valid way to proceed. You have multiple comparisons that you would be doing across 100 or more AE categories.

So that, without question, you would get several statistically significant results that were completely random, just because of the way statistics work. Right? One out of 20 is likely to be falsely statistically significant. So it's just not done and it's not meaningful. I'm sorry, what was the second part of your question?

And then, could you just clarify, is the panel going to see all the extension study AE data?

Yes, of course.

Thank you.

Okay. There are no more questions in the queue. I'd like to turn the call back to Ron for any closing remarks.

Thank you everyone for joining us and have a good day.

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Have a good day.