RE:RE:RE:RE:RE:Not surprising It's definitely possible that they've made learnings and this will help future plans, let's hope so.
Conservatism could lead them not to jump too early just as much as it might have caused them to act. I think it's more likely material events (or lack of them) have driven them to act. I'm still struck by it being a huge decision and you'd need a pretty clear picture of what is unfolding to act.
What would provide that clarity? Well is the 420 dose in the 1a it was a string of AEs in only 4 patients when the target was 6. Here it's unconvincing efficacy outweighed by AEs. We are arguing about the magnitude of these things when neither of us know for sure but I'm suggesting there must be little doubt to make the move, a pretty clear picture. What do you need for that in this patient group? Little or no efficacy??? Safety straying into unmanageable (or intolerable)??? Both??? We are in pretty clear negative territory no matter how much learning they've done.
JayjayUSA12007 wrote: Quote:"If they aren't being 'forced' to stop this by safety then I see no great harm in running this another few months to see what the full cohort tells you. It just sounds like a big decision to stop the trial and a relative small reason and solution. "
I disagree with this assessment. We always know that Thera management is very, very conservative and risk adverse. IMO, I think they made this move to err on the safe side.
The amended trial protocol likely will try to take into account existing data gathered in Phase 1a/b which will save time and efforts.