Re: Breakthrough Therapy Question
in response to
by
posted on
Jan 06, 2020 05:13PM
Yeah, Sun ... I'm not sure of a timeline. I "get" the 60 days part on the FDA's end. Just not sure how long it would have taken RVX to actually produce the application(s)? I was thinking it "could" probably be done within a couple of weeks of deciding to do it with available data, strattegy, and internal resources available but just guessing since I am not sure what all goes into it, exactly? Since Don has been suggesting 90-120 days (from Nov 16?), assuming he was thinking it would get filed in Dac or early January?