Specman4 asked who John Caroll is.... so I told him. I hope Brian Skorney is correct and the decision is AA ASAP. I have become so used to the finish line being moved further into the future that a quick decision by the FDA after getting the WB data would be a very happy surprise for me.
John Carroll wrote an article about Sarepta on the Fierce Biotech website a while back. You can google for it. If the decision truly is imminent then I am surprised. My prediction is
approval some time in September. ... But my guess is just a WAG... I have absolutely NO inside connections.
Hi again Michael, FWIW I think this is just noise. I could be wrong, but I really think this final decision is still months away and until then the stock will have wild swings between now and when we really know whether AA is granted.
Michael, I am, and have been long this stock for a LONG time. I fully expect approval of Eteplirsen, but I have learned the FDA tends to be S L O W. I'd be absolutely thrilled with an approval sooner rather than later... but I do not expect it.
What does "Prompt" mean to the FDA? To paraphrase George Carlin "How many prompts make a while?.
The twins are doing GREAT on Eteplirsen. Why do you think they are lobbying for Eteplirsen to be approved? Hint: it is because they know first hand that it works.
Just how far into the future is foreseeable? I always laugh when I hear that phrase. I do agree that the traders here should be watched closely though.
I don't think the company will release this information before the FDA makes its decision. IMO, we remain in the dark for a while longer.. The data is only material if the FDA says it is. Of course, the company can not selectively disclose anything...
The difference is Ebola, Malaria, Flu, and Zika are communicable. People, including the adcom panelists, are concerned that they may catch the diseases. No worries about that with DMD. Sad, but IMHO, it is a real factor in the endless delay tactics.
Of course, it being Friday with options expiring might have something to do with it. Still, it is nice to see upward movement.
Sean, Counting on the FDA to accelerate the Eteplirsen timeline seems like a longshot to me. I'll be thrilled if they grant AA on the 26th without further delay.
Silence is their best strategy at this point. They made their case very well. Nothing added now will help the cause... it might even hurt.
I think a decision either way will go to the 11th hour. There will be a lot of details to be ironed out. With either AA or CRL the FDA should spell out in clear terms exactly what has to happen for full approval. My bet remains AA is granted.