Monday, December 09, 2024 8:20:06 AM
Only after that did they change the endpoint. And doing so after an efficacy analysis is a cardinal sin in trials.
Only after that did they change the endpoint
They can change them whenever they want to. The issue is if an RA will consider the change to be a problem for a BLA/MAA.
You are completely clueless about FDA regulation. Again, the FDA ALLOWS endpoints to change/amend as long as the person who changes the endpoints(drafts a new SAP) is NOT biased from previous SAP/efficacy analysis. In there comes Duffy hired by NWBO.
YOU ARE CLUELESS AND A LIAR
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