Re: Breakthrough Therapy Question
in response to
by
posted on
Jan 05, 2020 06:21PM
Per the FDA website, they will respond to breakthrough applications within 60 days of receiving them:
What are the timelines for FDA to respond to a breakthrough therapy designation request?
FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.
DM's timeline from the CTAD CC:
"As we’ve mentioned before, we’re applying for breakthrough therapy status with both the FDA and the EMA. The process will take 90 to 120 days".
I can't tell, either, whether that timeline includes the FDA's 60 days to decide or is in addition to it.