Sarepta DMD Drug Will Get Speedy #FDA Approval, Says @adamfeuerstein Wha?!!! | Pharma Industry Regulation | Scoop.it

Sarepta shares were down only 24% since Monday [April 25, 2016], a surprisingly muted reaction to the advisory's panel negative votes. The stock could easily be down 50% or more if eteplirsen's approval chances in May were near zero.

 

But the actual outcome of Monday's eteplirsen advisory panel was more nuanced and decidedly less negative. After reading the statements and responses printed above, it's hard to deny Woodcock and the other top FDA officials were leaving the door open for accelerated approval of eteplirsen, regardless of the panel's recommendations.

 

"I don't think Woodcock would be anywhere close to that meeting and she wouldn't be saying positive things if she wasn't willing to exercise her authority and approve the drug," said Joe Edelman, CEO of Perceptive Advisors, a $1.5 billion long/short health care hedge fund which owns 2.4 million Sarepta shares.

 

Edelman is a longtime Sarepta bull. He said his confidence in the FDA granting accelerated approval to eteplirsen on or before May 26 is actually higher now after listening carefully to what Woodcock and the other FDA officials said at Monday's meeting.

 

"Woodcock is risking her reputation by talking positively about eteplirsen and then not approving it. She's taking pictures with these kids and their families and everyone is smiling. These kids should be viewing the panel's decision as a death sentence but they're standing with Woodcock and they're smiling. The mothers aren't complaining. Something is reassuring them. I don't think they know eteplirsen is going to be approved but quite possibly they were told to let the process play out."

 

That process should finally be resolved on or before May 26 when Woodcock signs off on the eteplirsen approval decision.