Maybe one of the experts like @ecoool2 or @otherperspective can clarify this comment from @Naughty Morty :
”The secondary role of the DMC is to halt a trial when there is overwhelming evidence of efficacy.“
I was under the impression that MSB were the ones that made this decision based on information provided by the DMC ?
It was also my understanding that when they did the full testing in 2017 that it was highly unlikely that MSB would have stopped the trial at this point even if it produced overwhelming evidence of efficacy because of the risks that the FDA for some reason may not accept these results for a BLA due to early termination of the trial (shorter trial time length) and if that happened we would need to start the trial all over again ?
Happy for the experts to correct any incorrect understandings of mine and thanks @Naughty Morty for your informative post
My apologies in advance if this post is a little hard to follow as I am trying to do it on my phone so not the best - that and being blonde isn’t helping either
Ann: DMC Completes Final Review of Phase 3 Heart Failure Trial, page-12
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