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Post# of 817826
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exwannabe

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exwannabe

Re: Lykiri post# 426668

Wednesday, 12/15/2021 11:33:57 AM

Wednesday, December 15, 2021 11:33:57 AM

Post# of 817826
Nothing in your post say anything about the IND change being accepted implying the PEI says the endpoints are good for approval.

I have said many times that the protocol change has been approved by PEI and MHRA. They are responsible for overseeing safe and ethical trial in their countries. They are (or were not at the time) responsible for approval decisions. It would be the EMA would have had to make that call.
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