It would depend on what words and numbers are accompanying that announcement.
If the trial is stopped, at that point, due to overwhelming efficacy, what would happen then? I doubt there would be FDA approval immediately, so one would hope that the EAP re-commences. Who really knows?
I doubt the DMC and FDA have been in this situation before. Again, one would hope that they’ve been discussing timeframes and hopefully may have a solution at hand.
if the trial isn’t stopped, at this point, it isn’t necessarily a bad thing. Again, there may be overwhelming efficacy, but due to the scenario outlined above, they may continue, in order to treat patients in dire need.
Without wishing to state the obvious, the only negative I can see is if it’s stopped due to futility, but don’t envisage that as being likely at all.
This is also supposition on my part, so would be interested in others’ opinion.
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