Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)  

Sarepta Therapeutics, Inc. (NASDAQ:SRPT)

Deutsche Bank dbAccess Health Care Conference Call

May 30, 2013 02:50 pm ET

Executives

Chris Garabedian – President and Chief Executive Officer

Analysts

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Good afternoon. My name is Robyn Karnauskas. I am one of the analysts at Deutsche Bank. It’s my pleasure to actually have Sarepta Therapeutics with us today, and we have the CEO, Chris Garabedian here to answer questions. This will be a fireside chat format. So for those of you who are listening to the webcast, if you want to ask a question log in to – just go to your website and type in www.yorn.com/db and then go to Sarepta Therapeutics, you can actually ask the questions anonymously. We actually already have an anonymous question posted. And you can take comments and Chris will respond and read out all these comments. So anything you have to say.

For those of you who want to be more recognized you could e-mail me directly and I’ll read your question anonymously. With that, thank you very much Chris.

Chris Garabedian

I am happy to be here Robyn.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

So what’s been going on? How are the things going? What’s been going on since your last update?

Chris Garabedian

Well, we’ve been focused on preparing these two summary papers that the FDA requested; one on dystrophin, as a surrogate marker in Duchenne Muscular Dystrophy; and the other one on our clinical outcomes from our Phase IIb program. And we have now a completed dose submitted them to the FDA and are working with them on the appropriate follow-up to discuss these papers, answer any questions or provide any clarifications if they have any questions related to the papers. And based on our minutes that we received from them, they said that, these papers should be enough to allow them to make the discussion of whether application submission could be accepted for filing under accelerated approval.

So it looks like that the meeting that we were hoping to have calendered by the end of June, it looks like that meeting would be calendered in the third quarter based on their checking with scheduling and also their need to take their time to review with teams internally and to make sure that they can meet internally on these papers with sufficient time. Although we have not nailed down a specific date it’s likely that that will likely happen in the third quarter of this summer. But we don’t have any more guidance on that.

We still are hopeful that we would have a communication around accelerated approval some time this summer. It’s hard to say if that’s going to be August or later than that, but that’s where we stand right now?

Robyn Karnauskas – Deutsche Bank Securities, Inc.

That’s helpful. And so as far as communication post submission how does that work? So there basically you submit the document and then they basically say, all right, we need time to read this and merely start thinking about it next – we expect the date for the meeting and then they go back and see if there is more questions.

Chris Garabedian

Yeah, I mean this is somewhat unique and that we sponsors typically put forth request for Type B or Type C meetings with specific questions that they want clarity on. That’s the sponsors prerogative, right? Which questions do they need guidance from the FDA on? This is the case where we’ve done that and the FDA came back and said, well, in order for us to answer those questions fully we want some more information. So now we’re providing that information and when we have provided that information and they, I am guessing are going to be scheduling internal meetings before they are prepared to have further discussions with us.

So we will be hopefully over the coming weeks finalizing the type of meeting and the follow up timing of that meeting. Yeah, but that’s all the clarity we have at this point.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

And when you say formalizing the type of meeting, can you help me understand that exactly?

Chris Garabedian

Well, they want to see this with a formal request for a Type B or Type C meeting to discuss it and follow up. So that again it’s not clear if this is a follow up.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Right. So whether it’s an informal or formal meeting.

Chris Garabedian

Yeah, that’s right.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

If it’s a formal meeting do you have to re-submit new questions?

Chris Garabedian

Not necessarily. Again it’s not a hard set of rules here. So I think we know what the questions we need to answer. Those are questions largely that were posed in the original request for the meeting. And so this is just something that we would get greater clarity on. So again, this is all I can say at this moment, but hopefully in the coming weeks we will have more clarity around that.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. Any update on the CMC meeting?

Chris Garabedian

Well, we still believe that that meeting can happen in the third quarter. So it looks like based on the scheduling of the follow-up meeting on these summary white papers, that would be towards the latter part of the third quarter. We have said that we really want to get good clarity around the acceptability of a solid approval filing before we hold that meeting. That has not stopped us from preparing the briefing documents from – we were not missing a step on scaling up manufacturing, collecting all the information that we would otherwise collect.

So there is no weight limiting step we’re waiting for from the FDA. But that meeting will have a different emphasis, depending on if we’re going to be pursuing an accelerated approval filing or not. If it’s under traditional review, we have some time right to make sure we do things all of the measured ways we would need to do it and to have a full data set required for a NDA filing under a full approval.

Under accelerated approval, we really need to get clarity on the flexibility of the agency on stability data, the level of comparability data that’s needed batch to batch as we scale up, how we can supplement CMC data on larger scale, so when we move from mid-scale to large-scale, what level of data do they need supplementally so that we can start in the case of an accelerated approval start distributing and selling drugs supplied for the large scale. So these are things that are very specific to an accelerated approval scenario and we don't want to hold that meeting until we have better clarity and guidance on that.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Got it. In any of these conversations does it come up in the – as far as in the non-CMC conversation with the regulatory portion of the FDA. Has it come up regarding the limited capacity and how you might handle that or do they want you to come up with a way to prioritizations, does that come up at all?

Chris Garabedian

Not to that level of detail. I think there is acknowledgment understanding that the FDA has been supportive of what I refer to as restricted launch. Right, well you don’t have drug supply to satisfy the potential full demand of the market. If we were dealing with another disease area where you see adoption curves or you might get 10% of the market, first year a 20% we wouldn’t be even having this discussion. But we think this may be a scenario like [Kalydeco], where you know the genetic subtypes that would required – would be amendable to the therapy and there is going to be that pent-up demand and if you look at Kalydeco’s experience, where the large majority of patients were adopting within the first year, that’s the type of scenario we want to prepare for and if the demand is that quick and that grade, then that’s where we have this issue that we probably – we wouldn’t have the full commercial supply at the time we would get an accelerated approval. And so I think the FDA is aware of that and they are aware that we are not stopping or missing a beat on trying to produce as much drug as quickly as possible.

We have not gotten to the level of detail of what that criteria would be of a restricted launch. They’ve used lotteries in the past. And so those would probably come after there was an understanding that we would be preparing for an accelerated approval launch.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. I have some questions from Yorn. So first question, have you applied for breakthrough status and if not why not? This goes to I guess when will we learn more about breakthrough?

Chris Garabedian

Yeah. So we have not applied for breakthrough status as we said here today. We are still evaluating that and we will continue to do so as we continue to have dialog with the FDA. And I have said previously that we are trying to really understand the benefits to us of having a breakthrough designation. We have fast track designation which confers many of the same benefits, which is a more frequent interaction with the FDA, involvement from the hierarchy of the FDA.

I’ve said before, we’re very happy with the responsiveness that we have seen from the FDA around this program. Right now, we believe we are getting the level of interaction that we want from the FDA. We believe that we have engagements from the hierarchy of the FDA and they are aware, and knowledgeable about this discussion around Eteplirsen and accelerated approval. And we really want to get further clarity on how they view our dystrophin and our clinical data set because as you know, breakthrough is based on a clinical signal of efficacy. And we believe we have that but we would like to gain clarity that the FDA sees it the way we do, that this six minute walk benefit and the clinical outcomes we’re seeing are supportive of a breakthrough designation.

Again we've been given no indication that it's not, but in order to pursue that we just would like better clarity and we don't see the real advantage where we sit today. Now that could change with further interactions with the FDA and we’ll provide updates on our strategy moving forward as it relates to breakthrough.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

The one question I get a lot is – you talked about the FDA wanting more data supporting dystrophin or maybe the correlation where people talk about maybe the FDA want the correlation with dystrophin and efficacy. But what does correlation really mean? And I am just wondering what your thoughts, well no one is really lighting up. This is the first company that’s got tons of questions, congratulations.

Chris Garabedian

I guess.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Yeah, so just what does correlation mean in your mind? I personally interpret it to mean most patients who have some benefits from the drug and they produce a longer form of dystrophin that they would have a clinical benefit as well. Not everyone and it doesn’t necessarily seem the people who respond the most actually have the fastest walk, but what do you think of it?

Chris Garabedian

Yeah, it’s a good question. We have to remember this is – we are arguing dystrophin as a surrogate marker. This is not a blood biomarker. And so we are taking a sample of muscle tissue and extrapolating what is going on in the broader muscular churn of these patients.

So already, you are dealing with a sample that you’re extrapolating information. Then you are trying to correlate that to an effort depended test which we believe is the most validate and you said most obviously the 6-minute walk which has been used by competitors in the space as a primary endpoint and has been used on the basis of approval in other neuromuscular conditions. But it is an effort depended test, which has a lot of variability and demographic, phenotypic characteristics have we believe a larger influence, age for example, a larger influence on your ability to do a certain distance on 6-minute walk than the level of dystrophin, right, they maybe in your muscles.

We believe there is a threshold that needs to be met on dystrophin and that maybe somewhat different patient to patient, but if you can go beyond that threshold to a substantial degree, which we believe we are where we are seeing approximately 50% of muscle fibers are showing positive for dystrophin, which confers the certain level of intensity that must be met to call it positive and we have seen correlation of the dystrophin intensity that we’ve measured with dystrophin positive fiber. So everything is moving in the right direction in these patients and we believe we are beyond that level of threshold where it would confer clinical benefit.

Now the difference is that we might see patient to patient, we think is more due to the phenotypic demographic, even the effort dependent rate. There is a psychological component to their trade. One boy who is really excited, right, to do the test versus one that just doesn’t like doing it. I mean that can have an impact itself. But what we were very impressed with in our dataset, and I shared this on our last earnings call, patient by patient level data is that through the 36-week timeframe which was the last time point before we confirmed dystrophin in the placebo cost over patients, every treatment patient – every treated patient that started out earlier treatment did better than every placebo patient. We think that’s significant. Every placebo patients from week 36 through week 74 showed stabilization after they had a sharp decline.

So changing the slope of a decline like that is not seen commonly in Duchenne. And so the fact that we have seen this in every patient was impressive to us. And we feel not only validates the treatment group which was stable largely over 74 weeks, but also showed stability in this crossover of which they were starting at a much lower baseline score.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Just one follow up question there. Why not show the correlation between dystrophin and the patients. You gave out specific patient data and we have to do a puzzle there out which one we think goes of with, why don’t you just give that data?

Chris Garabedian

Well, we think that the range of dystrophin that we have shown at 48 weeks is relatively tight. Right, so we think a between 30% to 60% dystrophin positive fibers with an average of 50%, right, are all meaningful levels. We also have to remember there were two boys who were twins written on ambulant they also produced dystrophin.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Right.

Chris Garabedian

So there is a perfect example of how you’re not going to see this tight correlation, because here are two boys, because they lost a lot of muscle mass in their legs. I mean in fact we have an independent MRI study that shows they had very little muscle in their legs and that’s probably why they couldn’t stand.

It’s not our inability to restore dystrophin in the muscles they have left and so there is a case where you have dystrophin restoration, but it’s not associated with any improvement on walk time, but we don’t consider them non-responders, we consider them invaluable on ambulatory measures, but when you look at the pulmonary function, they are doing well, if you look at their muscle strength in the upper extremity they are doing well, we have this thing called they 9-Hole Peg Test. They’ve showed stability on the 9-Hole Peg Test and so we think they are doing well on the drug even though they were too far gone to have benefited on ambulation from the drug.

So you will see this is the small data set but it is rich with information and you will see us continue to put data out there, even beyond six minute walk, right, you will see us – we are starting to dig deeper, now that we have more longitudinal data of the 74 weeks and beyond hopefully later this year and (inaudible) and we’ll have subsequent updates but we are digging deep to say right now that everybody is producing dystrophin and everybody should be benefiting from the drug in some capacity.

How do these boys overall – these twelve boys compare to natural history on pulmonary function, this is something that we don't have to sensor the twins, when we look at pulmonary function for example, we can look at full intensive treat so we are starting to look more deeply at the broader data set and of course we’ve provided much of this data to the FDA for their review, but the interpretation and analysis is still ongoing.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

You have a lot of questions.

Chris Garabedian

Yeah, that’s great.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

You now have to answer this quickly. In fact I really have never seen so many questions.

Chris Garabedian

It’s a rapid-fire round.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Yeah, ready, rapid-fire, 60 seconds or less.

Chris Garabedian

Okay.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

If you don’t have a tight correlation in your own data between dystrophin and clinical endpoint, how is that not proof of – God, there are more questions, in and out of itself that you are proposed or is invalid?

Chris Garabedian

Well, again, we don’t believe a tight correlation is possible with this sample of muscle biopsy to an effort dependent test. So we want to see good directional evidence and honestly, the outcomes that we see we believe is proof compared to what you would expect in this population that the dystrophin we are producing is having an effect.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

What is the status on partnership talks and any change of thought there?

Chris Garabedian

Yeah. We still have partners who are interested in doing a collaboration. We have made that a lower priority at this point mainly because we would like to have a better line of sight around accelerated approval and a potential commercial launch in the U.S. And what I would say is, there is nothing that we’re doing now that could be accelerated by a parker.

Our follow-on exons are moving along at a nice pace. Our manufacturing scale-up is going very well. We don’t think a partner could add more. We have a well capitalized balance sheet. And so right now, it has become a lower priority because we are not missing a beat on building out this entire program.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

In the event of a limited launch, would ambulation would be a factor in drug distribution, do you think?

Chris Garabedian

It’s too early to say and we would want to talk to the FDA about their thoughts around how to prioritize or restrict launch as it relates to ambulation, non-ambulation, age et cetera.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Are any samples from mid-scale manufacturing being evaluated at this time, if not when?

Chris Garabedian

We’ve been focused on reduction of practice runs and we’re pleased with the progress that we’ve seen. However the final drug supply and the analysis of that drug supply coming off of mid-scale production would not be – we wouldn't have a real good understanding of that until towards the end of the year, early next year again in the hopes of starting dosing in the first quarter of next year. I’d like to say, no news is good news here if anything were to trip up our ability as we see it to dose in the first quarter, we would communicate that, you would know it, the world would know it, surely after we knew that that was not feasible.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

First quarter dosing, how much stability data are you assuming?

Chris Garabedian

Three months.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Three months? Okay. If the FDA states that you can file for accelerated approval, when will you actually file, would it really be 2013 or 2014? It sounds like given the CMC timeline, it should be early 2014?

Chris Garabedian

Yeah, we’ve been relatively clear on this. Obviously, if we don't have mid-scale production ready to come offline until first quarter that you would be looking at 2014 filing and this is where we really need guidance on, how much data does the FDA need on CMC to determine the filing? Now the one qualification of that, it’s very possible that the FDA says you have a lot of data on stability, purity, consistency of batch to batch on small-scale, you could file on small-scale. But we would not have drug supply, so you could have an approved product, but we still need to supplement that with mid-scale data before we would actually sell commercial supply. So essentially we’re focused on mid-scale as the best scenario for a launch under accelerated approval and the optimum setting would be a 2014 scenario.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Why not release pulmonary data on all void and upper limited strength?

Chris Garabedian

Again, we have focused our broader clinical outcome analysis on the FDA papers. As we continue our dialog with them, I think you will start to see us expand the data that we provide. It’s interesting you mentioned pulmonary function, because I think next to 6-minute walk, it is probably the most looked upon and validated endpoint of the other exploratory measures that we had in the study. And we know in other neuromuscular conditions right it often is the basis of approval as a primary or co-primary endpoint. And so we are looking very closely, now that we have more longitudinal data, where it’s harder to show detecting benefit in 24 weeks, let’s say by 36. Now with more longitudinal data, it starts to become interesting versus what we would expect from natural history.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay, that’s helpful. And just a couple questions on competitions. I hear you may have some competition, I don’t know who?

Chris Garabedian

We do.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay. So anyway, so the other question here I got is, all right, to say present that data and say the safety profile is maybe, its okay and they get approval, how does that effect, given that you won’t be able to fully exploit the market, even if you get accelerated approval. How does the first to market affect your market opportunity for the first exon?

Chris Garabedian

Well, I think it depends on timing, right. I think generally of course everybody would love to be first to market, but I think more importantly just to be best in class. And we believe we have a best in class drug and we believe we can command the market share leadership position as a result.

Now, the timing of that and how quickly we can establish that will likely be dependent on whether we launch first or they launch first, how, what's the timing? I could envision a scenario where if they were to be approved, let's say six months before it looked like we would be approved. In that scenario, I would imagine some parents may choose if their boys are doing well and they are younger, let's say they are seven year olds and they are still clipping along at a good phase rather than subject their boy to a drug that might cause toxicities, proteinuria, injection side reactions, thrombocytopenia, coagulation issues what would have you that they might say, I’d rather wait for the better tolerated safer drug to start my child.

But even if that weren’t the case and we were dealing with a situation where the majority of patients were already on a competitive drug. Therefore best in class, we think that there are ways to switch safely and for a life long member, we are dealing with kids and we’re dealing with a life long treatment, and we don't know the long-term sequelae associated with the toxicities we have seen in the studies to date. And I think that will have a factor we believe, and so it’s hard to speculate when we’ll be approved, when they will be approved? What the data set is going to look like moving forward, but we’re prepared in either scenario?

Robyn Karnauskas – Deutsche Bank Securities, Inc.

What do you think of the safety data and patents and so in the (inaudible) F1?

Chris Garabedian

I don’t like to comment on competitive data, it’s all out there. That’s your job as an analyst to differentiate and characterize. I will say it’s nice to see our competitor have to deal with the public disclosures that we’ve had to deal with and that we expect – hope for more transparency around the data sets. And again I think it invites a lot more questions around the dataset as a public company. And so hopefully we will see a more even plain field as it relates to disclosures.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

They specifically add – meeting called out the Phase II, we had one patient at a really high increasing dystrophin that wasn’t like didn’t have a great response for 6-Minute Walk stable. Can you just tell us anything about that patient remind us this is from the Phase I, Phase II trauma the most recent study?

Chris Garabedian

I am sorry from their study?

Robyn Karnauskas – Deutsche Bank Securities, Inc.

From your study?

Chris Garabedian

From our study.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

They actually called it – they discussed that at (inaudible) full data.

Chris Garabedian

Okay. All right.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

I just thought maybe we talked to you about your data.

Chris Garabedian

Yeah that’s great, wonderful. So I think what you are referring to we had one patient at the 20 mg/kg dose who had 55% dystrophin positive fibers after 12 weeks of dosing, okay, which is not something we saw in any of the patients, in our 12 patient study. So what we would say is that first of all if you look at animal studies of the onset of dystrophin and this is what led us to do the design that we did and look at 12 versus 24 weeks. What you see in the animal studies, in the mouse model particularly and we saw this in the mouse model particularly. And we saw this in the dog model and [Kaufman] and his group did a dog study with very similar dose that we are using in the clinic, 40 mg/kg in a dystrophy dog model and we saw this patchy evolution of dystrophin.

So when you look at the musculature of these animals, in the short-term, you see a very spotty, not well distributed, not well diffused dystrophin. And so if you were to take a biopsy and get lucky to have picked a patch of muscle that actually we started to see at dystrophin, you get a very different answer than if you took nine other biopsies around that area and they’d all show up negative, okay.

What we think is powerful about our dataset is that not only did we see consistency across 24 samples at each time when we saw dystrophin. We saw that consistency across the sample, particularly the 48-week time point and that tells us that we should be confident that if you were to biopsy instead of 24 reads across 12 patients if you did 12 different biopsies in the same patient, we would expect to see a very similar conformity of that type of dystrophin. That’s what you want to see. If you see spotty dystrophin show-up that may just be representative of 19 and in this case, this is 19 patients, 17 of which have biopsy that one of them had a high level of dystrophin. We don’t know if that was a high level across his musculature or if that was just a biopsy sample to happen to have the first signs of dystrophin in the muscle.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Got it. That’s helpful. I know there is lot of questions in here, but I just want to ask you a couple of question separate from this. So I guess first, say you get the green light to go forward with accelerated approval or even if you don’t and you just get clarity on the regulatory path, how quickly can you start working on the other exons and say you are able to raise millions and millions of dollars like how aggressive would you be on developing these other exons quickly, so that maybe more competitive and more competitive timelines versus [Astrazeneca]?

Chris Garabedian

Yes, first of all we are applying a urgency to these other exons right now. As we have mentioned, we have pre-IND meetings that will be taking place this year on at least two of those. Where we want to get clarity on, is there any way to streamline based on the eteplirsen dataset that we produced robustly, a long term animal tox has been submitted in study reports to the FDA, supports the clinical safety that we are seeing and if they allow for more streamlined pre-clinical packages, we want to get those into the clinic as quickly as possible.

We are even talking to them about creative designs on our confirmatory study where we might have a [951] amenable cohort which might include Exon 53, Exon 45, Exon 50 amenable, where after a year of that confirmatory study they can roll right into a – let's call it a pivotal study on those other three exons where we would want to apply a standard dose and see similar outcome – similar inclusion criteria that we would use for eteplirsen confirmatory. That would be the fastest path to getting the next three exons let’s say approved.

Then we think we can supplement the other rare exons with in vitro data of exon skipping efficiency that we would have proven for four drugs that produce dystrophin of a certain range and that are safe. And so I presented a month or so ago at World Orphan Drug Congress and I think the presentation is now online on YouTube, but we outlined a specific pathway for kind of an accelerated development and accelerated approval of the follow-on exons and the rarest exons for DMD.

Look, hardly with parents all the time. It is very hard to talk to a mom who needs an Exon 53 for their child and Exon 45 or one of the rare exons and to tell them that it’s going to take many, many years before we can get to your boy’s exon target. I think there is a pathway, there is a way to accelerate development and we are trying to be thoughtful and understand the FDA has a specific standard and we think that the two can converge. We think we can do a development program that’s quick, that doesn’t compromise the standards of the FDA on making sure that they can have a safe and effective drug to all the boys who could benefit in the DMD population.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

And then I guess one question and this question I get a lot to, so I guess I get more comments rather than question but alternative to you. Do you wish that when you started talking about accelerated approval you didn’t talk about it as much as aggressively and it was more or like upside surprise for the street or do you think it was necessary in order to get lot of the thought leaders and the patients involved. So how do you think about like how you handle that, was that the right decision or the wrong decision?

Chris Garabedian

Some days, I come in to work in the media and the twitter feeds and the attention that has been brought to this company and to this accelerated approval decision, sometimes creates distractions and I have to answer a lot of phone calls and I have to address questions that are distracting from just the task at hand of drug development.

However, I feel the commitment to do everything in my power to get a drug that I believe is efficacious and safe to the patients that need it. And it's very hard to be committed to that and to express how we are trying to do that and avoid the perception of doing something that some believe us unprecedented or aggressive and we don't believe that, we believe in our drug, we understand the regulations and what the authority of the FDA is.

We believe we are meeting those demands and we hope that FDA does the right thing as it relates to accelerated approval. And that's my job as CEO, I don't want to be the one telling the parents, you know trust me, I know the biotech industry and I know the FDA, so I'm going to decide, we're not even going to try to pursue it and just trust me on this. Guess where their fire is going to be focused? It's going to be on me for being an idiot for not trying to get a drug to them as quickly as possible. So that's why I'm vocal about it and that's why I feel strongly because we believe in the product.

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Okay, all right, well thank you very much.

Chris Garabedian

Great thank you Robyn, I appreciate it.

Question-and-Answer Session

[No Q&A session for this event]

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: Sarepta Therapeutics' CEO Presents at Deutsche Bank dbAccess Health Care Conference (Transcript)
This Transcript
All Transcripts