No P-Value no proof the drug works. So no proof, no approval.
Let me extend a simple argument that gets ignored because it's an inconvenient truth. Having statistical significance means the drug works in a consistent manner that excludes the possibility of random occurrence. In other words the people that get better are getting better because of the drug and not on their own, or just getting lucky. The drug drives the resulting recovery.
CYDY has not shown that. No reason to approve it, anecdotal evidence is not what the FDA or any other regulator in the world operates off of. So blaming everyone but the company for bad trial results is a waste of energy.
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