Bio, that's not necessarily the roster set for SRPT's Adcom. It's the list of members of the CDER roster, but it's subject to change. The SRPT panel roster hasn't been officially set. When it is, it will be posted in the same location as the briefing documents.
Intentional. FDA knows what it is doing by not posting them. They'll be available the morning and probably not before.
The problem with your theory is that it completely flies in the face of Occam's razor. And historically, everything that has flied in the face of Occam's razor has ended up horribly. The Adcom panel and lack of voting questions will determine the best play from here. If no question is included, they are setting eteplirsen up for failure, just like they did with drisapersen.
He's simply being objective, and his view is exactly that. Pretending like the FDA wrote the BDs as they did simply to have a "cover" for approving eteplirsen is bunk. There is obviously someone very vocal at the FDA who is very opposed to eteplirsen seeing the light of day. Odds are not in favor of approval.
I could be wrong, but I'm pretty certain the evidence isn't indisputable. Call me crazy, but I base that on the stock price.
It's collective, but the louder voices such as Farkas are likely to carry the most weight.
Want there a panel a couple of years back related to eteplirsen where he was intentionally not included? If he isn't on the eteplirsen panel (i.e., Woodcock has taken his place), then look out above. That would be hugely bullish.
They're basically telling SRPT: You need to enroll placebo patients now, even though we initially told you that you don't have to.
They barely mentioned safety either. Basically, they don't want to mention anything that might improve eteplirsen's chances of approval. To me, that is forewarning. I wish it weren't, but it is. When the voting questions are officially released by Wednesday, that will paint a clearer picture. The FDA knows that patients and experts will likely be able to sway a positive vote. If they don't want that to happen, they will not include a voting question, which is exactly what they purposely did with Biomarin.
The FDA knows full well the kind of movement the BDs would cause for the stock. The fact that they released the document early tells me that something is rotten in the state of Denmark.
Well, I don't really know what to think and ultimately don't care one way or another. But I will say that if the questions do not include a vote for recommendation to approve, it's 90% likely game over for SRPT. Not even sure the P3 can save them given the BDs trashed that too, due to the lack of a placebo group.
Simp, those draft points I posted weren't in the back. They were in the middle of the document. So unsure how you saw questions at the back of the document. Doesn't add up.
Those aren't the BD questions. The questions are always included in the back, and in fact, are actually questions.