It seems more like a CRL on MOA... We have proven safety and efficacy.
It's questionable that having to detail the MOA is within their regulatory framework. Especially when it is still being couched within such a mechanistic approach (their must be a single measurable parameter, that explains it all). The truth is more likely to be, that there are multiple diverse cascades of action that contribute in different circumstances...
Why we are being forced to advance the theoretical field before approval is beyond me. For the last several hundred years humankind has benefited massively from practical scientific advances decades before the theoretical underpinnings were clearly understood...
What planet are the FDA on, page-148
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