Completely agree. In fact, the manufacturing facility only needs to be part of the pre-IND discussion and is not required to be in place for Phase 1. The company only needs to explain its plan for expanded testing, which could even involve a second party license to complete clinical testing.
Also, in a previous post, a resource not from the FDA, the outline for approval was incorrect. Phase 1 studies usually involves healthy individuals, yes, but in cases of critical need, end of life patients are often included in the first clinical round.
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