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User-840664

04/05/24 7:46 AM

#683362 RE: biosectinvestor #683353

“A Phase 3 Prospective Externally Controlled Cohort Trial”.

This is a remarkable title, as the investigators have re-analyzed the OS data of the study against published external controls and present this as a prospective trial. It is obvious, however, that this is not a prospective analysis but a post hoc retrospective analysis: the investigators had seen the data, both of their own study and of the cohorts taken for comparison and then decided to go ahead with cross-trial comparisons.'
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attilathehunt

04/05/24 10:43 AM

#683404 RE: biosectinvestor #683353

To do another trial would be an injustice...

Worse case is to do a P4 since safety is not an issue and we have seen promising and very real results.

To have them redo a P3 is not humane.