One other reason is that if the company can wait until the draft guidance Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry is finalized and officially issued by FDA.
I appreciate the company's painstaking and meticulous cares of not in any way offending FDA, but after so much times has passed after data lock, the company should not be worry too much.
It is what it is. Let it be determined by data.
Nonetheless, I do understand their continued cautiousness.
This is my last post. Good night!
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