RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:6.79 Saurus100 wrote: Yes, it is mandatory since it is an important event. Theratechnologies did when they filed for Egrifta
I'm sure if it mandatory, since I can't find many announcements for finished BLA submission, however, I find many many (not sure if it's all) announcements for FDA accepts BLA filing.
Taimed and Thera announced they will finish BLA filing by end of April. We don't know if they will announce finished filing or not? If not, IBA may be already on the timeframe between 60 days and 74 days.
Is there anyone could ask Thera?