News that FDA officials were present during 120 week testing, coupled with the outstanding data in the last 24 hrs. suggests that the FDA will overrule committee concerns over historical data and approve eteplirsen in the very near future. CG's presentation hinted at a way to move forward and my interpretation was that he wasn't talking about the PhaseIII trial design. His cryptic comments have the shorts closing their positions.
Bionerd, please point out the Chris comment that leads you to this conclusion. I missed it. Thanks.
"CG's presentation hinted at a way to move forward and my interpretation was that he wasn't talking about the PhaseIII trial design. His cryptic comments have the shorts closing their positions'
Copp, several times Chris stated that the company is meeting with the FDA to find a "pathway to regulatory approval." He never once said whether that pathway was through P3 or early approval. It was cryptic and went against his previous guidance where he stated that P3 was the pathway to regulatory approval (back in November).
Assuming the FDA reverses course--I believe it will--and SRPT gets a meeting with the FDA in February, I believe February would then be the latest we'd hear about it. Because if they don't reverse course before the meeting, and they do reverse course at the meeting, CG will have to send a press release immediately because that would be material information. At that point, the stock would shoot up 200%.
Conversely, if we don't hear anything by February, I'd wager it's full steam ahead with the P3 trial instead.
It's about time the vultures stopped circling. I'll believe it when I see it though. These are single minded, "we don't lose money" shorts. They are not finished, although a clear path forward from the FDA ought to initiate the short squeeze that we will all remember.