RE:RE:RE:RE:RE:I am almost convinced there's been a pushAgain, and unless it's not a question about waiting for administrative documents that need to be added to the FDA application form, the most logical explanation would be that they want to include the most optimal optimized patients in such FDA application so when the FDA press releases its final decision, we have the highest possible efficacy %s hitting the news wires.
The Dec. 16 press release from the FDA regarding the approval of Ferring's gene therapy gave us a good example on how the FDA proceeds.
One can also find all the FDA related communication documents regarding the FDA process that lead to Ferring's approval, and this, from inception. Lots of people involved in such process as this involves many aspects that only show how FGPstuck whining has to be ignored. The clown should do some digging. He would whine less and gain a better understanding of how the process works.