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Any news after the accererated approvals petition?

Hi.Where do things stand with FDA after the hundred thousand signature petition for accelerated approvals?

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Permalink Reply by Holly Cahoon on April 11, 2014 at 11:52am

I heard the FDA is still not willing to move forward. Anyone else hear anything?

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Permalink Reply by frankie on April 11, 2014 at 1:45pm

Just curious where you heard that "FDA still not willing to move forward."

The fact that Sarepta has provided no post-meeting update yet would suggest that you are correct and that the FDA has not changed it's stance, since a change in stance would be material information that the company would have to announce. But remember, FDA's current official position, confirmed in email's I and others have received as recently as yesterday, is that they have not made any final decisions regarding AA for Eteplirsin (which basically means "they are still not willing to move forward").

And that suggests there is still reason for optimism.