RE:Timing of Phase III for Panc Thanks. That does help. Good information.
My question to that would be as the original standard Phase II trail was completed back in 2014-2016, some of that process would have already been started and in place. i would assume.
I assume the 'Special Protocal' letter and letter of favour, came from that process back in around 2016.
The other side trials IND, AWARE-1 and BRACELET-1 were only additional information building upon the original standard Phase II trail and Phase III trail application.
So my question would be, do those side trails still require the 90 days? Or, would/could their data just be added into the original Phase II trail final documents and request for a Phase III trial, as those side trails were only building on the previous Phase IIi application documents that are already in the FDA process?
I have no idea, but if the FDA already started that process back in 2016, does that cut those time lines?
I would think that with the porceess started in 2016, they FDA might be able to expidite that procees under the original Phase III application ptha5 occurred around 2016???
Purely speculation there.
I have no idea ... thanks for the note. That would helps to suggest potentail time lines.