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exwannabe

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exwannabe

Re: CrashOverride post# 519368

Wednesday, 10/05/2022 11:46:32 AM

Wednesday, October 05, 2022 11:46:32 AM

Post# of 695565

MHRA endorsement of trial design,...


The MHRA never endorsed the design as being suitable for an approval.

The change to the IND meant that MHRA considered the change safe for patients.

The PIP says they consider the design suitable for a P2. Many P2s have used historical controls.
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