Quite unusual for the FDA not to follow US Code, the first time I've seen this. Notwithstanding that the FDA is being gutted by RFK, if the FDA has already said the non-clinical package of the IND is inadequate why is there no letter to explain what those inadequacies are? If they know what it is surely they can put it in a letter! How many people do they need to do this??
I'm not buying the FDA's response here, this looks dodgy.
Quite unusual for the FDA not to follow US Code, the first time...
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