RE:What is Accelerated approval? Thanks and great posts West!
What this means for ONC is the Standard Type C meetings and application process is no longer ONC's required pathway for mBC and now Panc. It will be a shorter process.
IMHO we could very well see Approval of the Phase II/III Panc registration trail before end of 2022 or very soon into 2023.
When that happens ONC will officially be a Phase III drug company. Its coming faster than I expected.
Timing on that aside, IMHO this panc FAST TRACK designation puts even further pressures on Pfizer to speed up their decission making process, and also puts more pressure on Roche to get a deal done before Pfizer completes their 90 day exclusivity period.
Wow, this was totally out of left field, I was not expecting this kind of stuff until mid Q1 2023.
This proves heavy FDA discussions are underway!
What else is underway... would love to be a fly on the walls over there.... LOL
Final approval of a Phase II/III regustration study will require the finalized scope of the trial. I don't think it is going to take ONC long to put that together. I don't think it is going to take long for the FDA to review and approve, my guess is, they all already know what it needs to be, as ONC, ROCHE and the FDA all have been dealing with real time data all through panc trial, and this FAST TRACK designation adds to prove the FDA is on top of things already....
Now... my question is.... will ROCHE want input on the Phase II/III panc application, will ROCHE want to finalize the application... I assume ROCHE is already heavily involved with the FDA discussions as well as ROCHE's drug is part of that combination drug therapy...does it matter who makes the application...???
I see this FTD as a huge jump forward in timing..