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exwannabe

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exwannabe

Re: CrashOverride post# 522835

Tuesday, 10/18/2022 1:11:46 PM

Tuesday, October 18, 2022 1:11:46 PM

Post# of 823188

MHRA signed off on the trial. DCVax will soon be approved.


The MHRA approved a plan to run two P2s using ECAs. This has been reasonably common for decades.

The PIP trials are not pivotal. The standard of proof needed is far different.

The ECA will be defined in advance of the trials being run. Not after finding out randomized endpoints failed.

When planned in advance they could use selection criterion that can be matched to ECAs.

It will not be the same SAP.
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