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Re: dr_lowenstein post# 528365

Sunday, 11/06/2022 11:59:08 AM

Sunday, November 06, 2022 11:59:08 AM

Post# of 689198
You said

yeah FDA will like that


There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval



Then, later...

FDA lifts the partial clinical hold on PIII trial. With Northwest Bio having decided to close enrollment 17 subjects short of its target, the lifting of the partial clinical hold will not trigger renewed recruitment in the trial. But the FDA action clears a regulatory concern for Northwest Bio.



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