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longfellow95

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longfellow95

Re: HappyLibrarian post# 366442

Thursday, 04/01/2021 1:37:33 PM

Thursday, April 01, 2021 1:37:33 PM

Post# of 700889
We don't know that the FDA green-lighted what NWBO proposed in the revised SAP.
If they didn't accept it, there would have been no update required to the trials site.
I'm really rather happy that at least two regulators have apparently accepted the changes.

But I don't disagree that they have shown some sloppiness in amending/updating listings and filings etc, in the way that they routinely should.
Equally, I'm not surprised by that.
Large Pharma have whole departments dedicated to this sort of thing.
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