RE:Multiple thoughts.Actually Canadafan, all we know is that ONCY told us that the FDA suggested they find biomarkers...
THIS was not a command, not an instruction, but advice... FDA granted ONCY a SPA for a Phase III in mBC over 5 years ago.
The purpose of this was that, if ONCY were to have seen the same proportion of responders in a larger Phase III trial (essential a repeat of IND-213). then their BLA would be approvable.
They had a big green light to go... and they had Adlai Nortye as a partner to cover SE Asia, and who would run their own Phase III in China...
But NO, In order to reduce population size in the Phase III (they reckoned at the time 450 patients), Matt ran the other studies... because it would be quicker..!! LOL yep, that worked out well didn't it.
And so here we are 5 years later, still with "potential" biomarkers, awaiting ourcome of type C meeting with FDA. IF the FDA accepts ONCY's biomarkers, they will be able to pre-select liekly responders to the trial, and lower the number of participants required.. but this Phase III will still need funding, and will take 3 years... so NO BLA until 2028... and no approval until 28/29. That is the earliest.
Now you tell me how you think Matt did for saving time to get to market... if by year end they still have no partner, mBC will NOT happen. At this point management just seem to be stringing investors along until Panc trial delivers new hope...