... give me an honest answer about. I see in the recent coverage that Cowen estimates approval in 2016. Does that sound right? Am I misunderstanding something. I thought there was some chance of early approval this quarter. Please clarify. Thanks in advance.
Cowen is looking longer term and saying without AA (which I think AA is a lock) the stock will still be a big gainer. This is one of those rare biotech situations where even if SRPT doesn't get AA (again I think they will) the company still has a great future. The stock "will" go down in the short run which will provide a good opportunity for longer-term investor, like me, to pick up shares on the cheap. AA or no AA SRPT has great management and a great future....you'll just get your first payday quicker with AA.
Early approval yes. This quarter no. What will happen this Q is the team will visit with FDA for a end of phase II meeting, and on the agenda will be a discussion of using the current data to apply for Accelerated approval (AA). If the FDA likes the data and the plans for manufacturing etc, they will 'invite' SRPT to apply for AA. This is gong to be seen as a liely approval nod, even though they have yet to formally apply. Some time after the meeting SRPT will tell the arket what the FDA meeting was all about. That is the catalyst, the advice they get from FDA. Later in the year SRPT will then announce that they have indeed filed, and some time less than 6 months after that FDA will give thunmbs up or down on AA. If they give a thumbs down, it doesn't mean a failure it means they will have to do a ph3 trial and then apply for market approval via standard approach. The copany still makes sense for investing either way, the question is how soo to the big payday for investors. If they (FDA) give a nod to an AA application, then there are three big inflection points this year. 1) When FDA gives nod 2) When SRPT announces they applied for AA and 3) When FDA takes a record of
This also should be a push for Platform approval as well.Meaning all exons should be included,it is not cost effective to do a trial for every rare exon for dmd.Since exon 51 is just 13 percent of dmd ,one could approve it early based on keeping a child alive with this drug verses certain death.""based on this new drug not known to man very long term we shall keep it going with one more exon in another trial and if we see the same benefit like exon 51 in this second exon skipping trial ,platform approval shall it be.
Great post mainlylobster. As far as the Accelerated Approval timeline goes, when exactly do you think the FDA will make a decision on that? If not in the 1st Quarter, what are the chances it happens in the 2nd Quarter? Or more specifically, before May or August?
I've been long on SRPT for years, I am trying to decide between buying May or August Call options.
Sentiment: Strong Buy
Thanks Lobsterman - In your opinion (because there is no answer based on facts), would the probability that earlier approval would save lives accelerate the approval process? Also, do you agree that probability is the right word here?
IMO, I can't imagine FDA approval later than this year.