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Posted On: 04/27/2024 12:17:37 PM
Post# of 148876
Yes, and here is the reason: the holds had nothing to do with the FDA's thoughts on whether or not LL is viable, only if it was meeting certain specifications/standards up to this point. It is only after the requested information is provided to the FDA in the correct fashion that they would determine whether or not to approve the molecule in the end.
CYDY needed to (and did) provide the additional information requested by the FDA, and now they can go forward with getting the next information needed by the FDA to continue moving forward.
CYDY needed to (and did) provide the additional information requested by the FDA, and now they can go forward with getting the next information needed by the FDA to continue moving forward.
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