Adam F " Bring on FDA Panel. It's a Positive for SRPT " linked
The Street 2/1/13
@HemPaddy asks, Will Sarepta face a panel if FDA allows AA [accelerated approval] submission?"
It's reasonable to assume FDA will convene an advisory panel to review eteplirsen if the agency allows Sarepta Therapeutics (SRPT_) to file for accelerated approval. I'd say a panel is a near certainty, given the novel exon-skipping mechanism of eteplirsen and the lingering controversy over the small number of Duchenne muscular dystrophy patients with the drug to date.
I don't see an eteplirsen advisory panel as a negative. In fact, I'd wager that a panel would bolster the drug's chances of being approved early. The convincing efficacy and safety data generated already, coupled with powerful patient testimony, would make it extremely difficult for any expert sitting on the panel to vote against eteplirsen.
I say, bring on FDA panel. It's a positive for Sarepta.