Hi Micheal, The drug works and is safe..... but never underestimate the power of the FDA to delay. It could get approved this week... but the FDA has no sense of urgency about it.
The only way we find out what happened to Gary is if he tells us. He may be just tired of posting. He may have health problems himself. He may have sold and moved on. He may have died. Anything is possible.
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.