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exwannabe

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exwannabe

Re: hoffmann6383 post# 590995

Friday, 05/05/2023 5:11:22 AM

Friday, May 05, 2023 5:11:22 AM

Post# of 824057

Correct, the MHRA explicitly approved the trial design and the fda also likely approved the design.


Nonsense.

The MHRA said in accepting the PIP that using pre-specified external controls in a single arm trial not designed for approval is reasonable for an early stage trial to advance the state of knowledge.

That is far different from saying implementing an ECA after a randomized trial failed the predefined endpoints is valid for establishing proof of efficacy.
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