Did the FDA reset the BLA clock when the "remainin
Post# of 155127
(Total Views: 709)
Posted On: 07/11/2020 2:34:23 AM
Did the FDA reset the BLA clock when the "remaining tables" were provided on May 11th? If so, July 10 is 60 days, when they can reply, and not 74 days, when they have to reply.
In what I've read, the FDA only communicates really good (priority review) or really bad (refuse to file) news at the 60 day mark. This would make NP's use of the word "could" in the June 8 PR precisely correct, and, as you suggest, no news would mean we've passed the RTF hurdle.
This scenario is likely entirely wrong, and NP will have a PR on the BLA Monday morning, but, if not, this is one of many possible "no biggie" explanations.
My guess is, with FDA resources strained with COVID work, and this approval being focused on a combo therapy, it might be hard to get an FDA commitment for a priority review right now. That wouldn't show disrespect for leronlimab.
In what I've read, the FDA only communicates really good (priority review) or really bad (refuse to file) news at the 60 day mark. This would make NP's use of the word "could" in the June 8 PR precisely correct, and, as you suggest, no news would mean we've passed the RTF hurdle.
This scenario is likely entirely wrong, and NP will have a PR on the BLA Monday morning, but, if not, this is one of many possible "no biggie" explanations.
My guess is, with FDA resources strained with COVID work, and this approval being focused on a combo therapy, it might be hard to get an FDA commitment for a priority review right now. That wouldn't show disrespect for leronlimab.
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