If this is part of your short thesis, good luck with that.
You have to apply for Breakthrough Therapy Designation for it to be granted. Sarepta chose not no apply. They already had Fast Track and Orphan Drug designations and already had the level of communication with the FDA that Breakthrough Designation is intended to provide. Maybe Sarepta should have applied but it was a company decision that it was unnecessary. Further, in an FDA press release last Fall they were explicit that when the Eteplirsen NDA is filed it will receive Priority Review.
bionerd, I love your contribution on the science. But I am pretty sure that you have misread simp. He can be annoying but I find him more accurately in tune with the emotions of the market than most anyone here. He has posted some creative fibs here, but they are so transparent that I can't imagine his intent is anything other than entertainment. I don't know if he has ever been short, but I am confident he is a savvy long at the moment.
Almost certainly a Citibank Client(s) was short SRPT on early advice from Werber. He also was an advisor in the sale of Propensa to Biomarin in a desperate effort to bail out some of the Citibank clients invested in Propensa (before their failed Phase 3). As the data has been increasingly overwhelming in favor of Sarepta having the superior drug, Werber was the emperor without clothes left with nothing but empty animosity toward Sarepta sprinkled with a few lies. I suspect Citibank is not one bit sorry to see him leave.
It wasn't enough for him to be a Propensa cheerleader after Citibank was the underwriter for their public offering. He later resorted to lying about Sarepta. Who can forget this:
Citi Analyst's Embarrassing About-Face On Sarepta Doc's Views
By Adam Feuerstein | 09/27/13 - 11:52 AM EDT
thigrisrk, I certainly agree with that, and the reference to "conditional" approval merely refers to the post-approval Confirmatory Trials which are going to continue under any scenario.
I won't argue the details. We are on the same side. What I expect this fall is Conditional Accelerated Approval. The next step is Class Approval for approving all the other exons at light speed.
lol. I think you are splitting hairs hw. I'm sure there is a difference between accelerated approval and conditional approval but it's lost on me.
Of course it will take a break. But what is your point. Are you suggesting people sell and then buy back in before the next leg up. Trying to time the next leg up is like trying to time yesterday's announcement.
The long's know the milestones that are coming, but if we tried to time them we'd have missed out on today. The serious long's may do some hedging, but we are not gambling we are investing. It's a buy and hold for most of us.
There has been several positive commentary from PPMD about ETEP in the last 2 years. And when the FDA again delayed filing of the ETEP NDA with new roadblocks last November, Pat Furlong (PPMD) wrote the FDA very bluntly expressing her concern about the delay.
What is the date of that comment? One sentence is already already untrue: "we envision that BioMarin’s
drisapersen will also be filed in April, 2015. So both drugs will be racing to the
market." Biomarin's drisapersen NDA was submitted in April but has not been accepted yet by the FDA for filing.
The person that so offended and criticized PPMD (yes you) that you have been banned not once but twice from posting on their website (yes you) is now the expert on influence with PPMD. Oh please.
The Sarepta mgmt reported several times the FDA did NOT require the fourth biopsy. If any analyst suggested otherwise that tells you a lot about their accuracy.