I wonder what the protocol is.
Supposed we've got overwhelming success after 90 patients, is it a binary decision.
i.e. either:
1. stop the trial because of the overwhelming success
OR
2. continue the trial as the trial results are not black and white enough?
Is it possible to have approval for overwhelming success and yet still continue to perform the full trial of 300 patients - as a confirmationary trial?
Cell Therapy News/Articles, page-2964
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