Likewise! Its not an outright rejection, because if you read the regulations - https://www.ecfr.gov/cgi-bin/text-idx?SID=267602869dc495c1d59379706cf83c90&mc=true&node=se21.5.314_1110&rgn=div8 and
the reasons for an NDA refusal here - https://www.ecfr.gov/cgi-bin/text-idx?SID=267602869dc495c1d59379706cf83c90&mc=true&node=se21.5.314_1125&rgn=div8
The FDA just wants more evidence. Its not a rejection of the current evidence.
Its stem cells. Its a revolutionary method here.
The best case scenario is to see approval via the accelerated approval pathway, and then a post-marketing study as a condition in the approval.
This I believe will be given because its a huge unmet need!
Next steps discussion, page-7
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