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Re: hoffmann6383 post# 606731

Wednesday, 07/05/2023 2:04:51 PM

Wednesday, July 05, 2023 2:04:51 PM

Post# of 822479
Hi hoffman.

Can you explain what you mean by the FDA approved it? By my read of regulations and law the FDA allows an IND if it is safe and ethical. Given the trial was long over hard for any change to be a concern for patients.

And when did the FDA say they "approved" it/ Per LL it was by saying nothing for 60 days. But the SAP was not even signed by Bosh 9/23/2020, so how did the FDA implicitly "approve" it by 10/5/2020?

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