RE:RE:RE:TH-1902 pause is no reason to blame management Is the MD Anderson thing a pure guess or you've heard rumours that is where it came from?
I'm a big fan this was a decision made fairly rapidly but in my mind that would generally point to a worsening toxicity situation. Efficacy should be more like a slow inevitability, made they crossed a line on that but two third thru the trial doesn't feel like that moment (unless they have next to nothing).
I would have thought the CRO and THTX would be the people who had the greatest oversight and eyes on all the data and be the ones who could make this type of call. But in general I don't know the full role of the Principal Investigator.
This has paused two thirds through the trial. If it genuinely was not because the toxicity had become unmanageable and it was because of unconvincing efficacy then I have to think that there really wasn't much at all in terms of efficacy. Close to nothing really. Because the bar for success here wasn't so high, so almost any level of RECIST response would put you in a position where the next responder might get you over the line. You can't know that isn't coming with the next patient.
Without any details it's hard to see where even the smallest positive is here, the thing that makes continuing with th1902 worthwhile. I could see them thinking the SORT1 tech not being dead but that would take them back to the start. Alternatively there might be scenarios here that are pretty fatal to the whole tech or at least require a much more fundamental rethink.
The biggest problem is we are in the dark. What exactly does unconvincing efficacy mean? You really can't imagine anything but the worst without some info.
SPCEO1 wrote: From what I have been told from those who have spoken to management, TH did not hear they had to pause the trial until mid-day on last Thursday. My guess is the doctor at MD Anderson made that call and TH may have been surprised by it, or at least by the timing of it. I would also guess, they knew they had enrollment issues that were likely related to efficacy not being good enough. Perhaps they had some better efficacy indications early on that later waned which is why we went from the key to unlock cancer to de-emphasizing cancer on the Q3 call? Alternatively, Paul was in marketing mode in September and the board forced him to stop using such optimistic language in October.
I am sure these guesses don't capture the truth of the matter but may be in the ballpark.
Adonis wrote: So Why paul told some weeks early # we have the key of cancer # just after that the disaster happened..