RE:RE:RE:RE:RE:RE:RE:Themandyman Heloo Bio, when do you think ryplazym would be approved and why this date?
From what i understand
- FDA approved new CMC
- Consequently PLI send te new bacth for trials? how long it takes?
- will we get e nez PDUFA? if yes when we should expect it
Dont we need 12 months of data with new bacth?
thanks