Starfe, I have been curious about something. Maybe enough time has passed you won't mind answering. A couple years ago you posted about meeting with CG where he expressed frustration about a particular Sarepta antagonist at the FDA. Was it Farkas or Bastings?
I am with you on that easy. I have also wondered how many more months it would take Farkas to review and verify and re-review and reverify and consult with Hoffman and move the goalpost again before the AA decision. Fortunately, I don't think Farkas is in charge of this review anymore.
John Carroll never said AA decision is imminent. He quoted Brian Skorney as saying it is imminent. Brian Skorney is an analyst worth listening to. Brian Skorney essentially said that he believes Sarepta has the new WB data in hand and once the FDA sees it they won't need long to make a decision. Scorney further believes an increase in dystrophin in ANY amount above baseline will lead to approval. Imminent could be Monday or two weeks from now.
It is a fact that Eric Hoffman argued to the FDA that Sarepta's dystrophin data was insufficient. His arguments are in his presentation at the FDA Workshop on March 20, 2015, and those arguments were repeated verbatim in the FDA Briefing Documents to the exclusion of other expert opinions. Dr. Louis Kunkel has effectively dispelled the validity of Hoffman's arguments, but it remains that Hoffman was the principal advisor to the FDA before and during the Etep Review about how much dystrophin would be considered clinically meaningful.
It is also a fact that certain hedge funds knew the .9% dystrophin number months before other investors. I watched a video before the briefing documents were released where that dystrophin number was provided as the bear thesis. I wondered at the time how they could possibly know that. That is something that only Sarepta and the FDA would have known at the time. Who else knew that .9% dystrophin number in advance of the briefing documents besides Sarepta and the FDA? For one, Eric Hoffman. The FDA would have shared it with him seeking his opinion. You can start to narrow down where the hedge funds shorting the stock may have been getting their insider news.
I do not believe the company could legally provide new WB data to the underwriters without disclosing it publicly. The underwriters do get to see the exact FDA communications but only after the essence of those communications has already been publicly PR'd. Which is exactly why the company disclosed that the FDA requested WB on 13 new patients. If they were going to tell that to the underwriters, they also had to release it to the public. Finally, if the underwriters had the WB data and is is as expected, the price set for the secondary would have been much more. At the time of the underwriting, the company would not have had the WB data or they would have had to disclose it publicly before the underwriting took place.
Last night you predicted today: "It will crater pre-market and continue throughout the day....."
You seriously think if they weren't confident they were on track for near term approval they would only raise $37m? Lol.
I was considering your perspective on SMMT until I saw your ignorant comments on SRPT. Also very sloppy and deceptive to call yourself a P.I. on a biotech message board. You would know that in the drug development business, P.I. is the common reference for the Principal Investigator involved in the clinical trial.
I didn't see anywhere Bionerd suggesting that. The most optimistic scenario is full approval for Etep. That would expedite the path to platform approval for the other exons based on Dystrophin. I don't expect that, but would be one bold move by the FDA.
or they think the decision will cause public harm. Since no one has seriously expressed concerns about the safety of the drug, that does leave only the reason you suggesting.
When one of the AdComm panel members said it was clear the boys were improving but he can't be sure it was caused by the increase in dystrophin you have to shake your head in amazement. He couldn't even make the connection that he only had to find it was "reasonably likely"
By the end of the AdComm I think Woodcock had plenty of company among the FDA leadership that felt there was a basis for Accelerated Approval. Specifically, Temple, Unger and Dunn. The holdout would be Bastings. Where some measure of power is concerned, Farkas is almost irrelevant.
Oneway, I know you have watched the AdComm webcast a few times to reach most of your conclusions. Before I read your comment here I decided to watch the portions of the webcast again where the FDA was commenting or presenting and I reached a similar assessment of Eric Bastings. I don't know if the impasse is a DPO or merely smoothing through disagreements, but I agree with you that the person likely to be the source of the impasse is Bastings. If there is a DPO it probably came from him. Farkas appears to have been the ninny trying to carry his bosses water.
Why would Farkas or another person at the FDA make a last ditch petition against approval? There is no safety issue so the reason would not be based on a moral objection. At the FDA if the boss wants approval the staff helps make it happen unless they have honorable conscientious objections in which case their intransigence can be forgiven. Intransigence based on a bruised ego is certainly a career killer. The only reason I can think of for anyone below Janet Woodcock to strenuously continue to argue against approval and prolong the process through petition is that their hedge fund payday disappears. Someone at the FDA is being secretly paid in this ordeal.