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Re: exwannabe post# 736360

Monday, 12/09/2024 8:20:06 AM

Monday, December 09, 2024 8:20:06 AM

Post# of 818305

Only after that did they change the endpoint. And doing so after an efficacy analysis is a cardinal sin in trials.

WRONG AGAIN this is just your biased opinion that is all.

Only after that did they change the endpoint

The FDA ALLOWS to change endpoints after AI study DoDo look at Anavex they changed the endpoints after datalock and have now submitted MAA. You were never able to quote the FDA where your rehashed BS statement is confirmed

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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