Replies to post #164391 on Biotech Values

[ronpopeil]

Chris Garabedian has suggested many times that they will not file for AA without the FDA's blessing. Therefore, if they do file, presume it was the FDA that gave the company the nod. Additionally, Chris also said in the last call that if they did not get the nod, they would likely wait for the FDA minutes before saying anything. If they did get the nod, they would announce the decision right away. I would think todays conference call would be a positive sign since the meeting with the fda probably took place 1-2 days ago

[drbio45]

No company we know filed accelerated approval without FDA's explicit yes for filing which is why very few NDA/BLA filed under subpart H regulation.

I think it was pretty clear from the conference call that SRPT did not have an explicit yes