RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Accelerated Approval, surrogate endpoints, registration The concern I have is that while all Phase 3 trials are inherently 'registration enabling,' not all 'registration enabling' trials are Phase 3.
The alteration made to ONC's investor presentation, where all references to Phase 3 were replaced with 'registration enabling' or similar phrases, seems like a preemptive measure by ONC to address the disappointment arising from the potential that there will be no Phase 3 trial this year in Panc, and most certainly, no Phase 3 trial in BC (as if that was ever in question).
They'll likely instead announce yet another small P2 in Panc and then try to pass it off as a quicker path to registration, when in fact it is almost certainly due to ONC's unmitigated disaster when it comes to securing partnership and funding for a legitimate P3.
Funny to go back to announcments and news from 2020-2021 when ONC was promissing a P3 in BC that would begin in 2022 timeframe.
The P3 in BC will never happen - I think even ONC's most ardent supporters may have accepted that fateful outcome.
And now here's ONC ... ON THE VERGE OF A P3 in PANC.. that has now been rebranded as a "registration enabling study" ... Let's see where they are in 2026, shall we?