RE:RE:RE:RE:RE:Not surprisingI think one can safely say they made this change because they were not getting the results required to move forward. If they kept going, they would be wasting our money. So, they made the sensible call to try another approach to see if they can find the results they originally expected.
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.