So the CEO meets with the FDA later this month. What are the chances that the FDA issue the minutes of the meeting so that Sarepta makes the announcement before April 15 as to whther or not the FDA supports Sarepta's application for AA?
I put the probability at 30% to 50%, because I think the FDA, lke any bureaucracy, will take time to issue the minutes because this AA meeting will likely create a precedent (e.e, size of patient pool, etc.), and because, even if the FDA issues them quickly, chances are that Sarepta will have follow-up questions for the FDA before they make any public announcement.
Views anyone, especially from those of you who are familiar with other companies' AA experiences?
I also think the FDA will take close to the maximum 30-days after the meeting to give the results to Sarepta, and Sarepta will take another days or two to issue any releases. I actually like the fact that the CEO has kept the actual date of the meeting secret. The less shorts know about their timelines the better.
While we have to wait 30 days to know what was said at the meeting, the company will know right away obviously. I think this will give them a 30-day window to get things in motion. Things I expect:
1. Partnerships of any kind have obviously been put on hold till after the decision from the FDA. Otherwise we would have seen something done by now.
2. If they get nod to file for AA, I expect a European partner announced around the same time. Also, by the time we know about the verdict on filing for AA, the company will have lined up large scale manufacturing in preparation for manufacturing meeting with FDA. With all this lining up at once, and definite near-term timelines toward profitability, the stock price will go up multiples of where it is now.
3. If they don't get the nod for AA, I think they could use 30-day window to set up a partnership that would allow them to earn large milestone payments over the course of the Phase III, and FDA submission in exchange for a percentage of future royalties. This announcement would hugely offset any disappointment from not getting accelerated approval.
4. Forget 3 because I think they are getting AA.
5. Like I have said previously, let the market sleep on this one for a while. I am guessing things will probably get a bit boring this month and early April excitement begins.
I think regardless of what happens, the company intends to keep all rights to eteplirsen solely for themselves. At least in the United States. Chris has more or less said the same himself. Eteplirsen is going to sell itself, so there's no need for a partner.
I think they will eventually find an ex-U.S. partner, however.
If the FDA takes 30 days to inform SRPT of the decision it will lead to serious morbidity and mortality issues! Specifically, usagary, simp, iyadncheryl, zwerp, starfe, jim fredericskburg, sdijc, copp and viper will become apoplectic, and likely suffer fatal hissy fits. Prior to succumbing to terminal impatience over not being able to cash out of SRPT, their level of futile posting will reach such a fever pitch as to crash not only the Yahoo servers but probably the entire internet, leading to worldwide market collapse, ushering in a post-technological apocalyptic dark age. Therefore, in the interest of saving not only those afflicted with DMD, but indeed, all of humanity, the FDA will decide sooner rather than later, and inform the OCD posters on this board first to head off any broader calamity.