Replies to post #164386 on Biotech Values

[jq1234]

You are off base regarding accelerated approval filing. This isn't regular NDA filing, this is under subpart H regulation. 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. The only rejection, refuse to file issued by FDA for accelerated approval filing was Genetech's TDM1 for breast cancer.

I don't know what SRPT will announce tomorrow. To say they will file for accelerated approval without FDA explicit yes doesn't understand sub part H regulation. FDA will simply issue refuse to file.