The FDA is clear on this, you can either:
1. Get excellent clinical efficacy results with no safety issues and they don't really care about replicating the mechanism of action in-vivo with in-vitro, or;
2.
Source: https://pink.citeline.com/-/media/supporting-documents/pink-sheet/2020/08/fda-briefing-document-on-remestemcel-l-am-session.pdf?rev=222f51497a0f49c294091e6ad844115c&hash=93D88D09ED488698D719E3EA21DD7334
The Phase I/IIb Nereid Study Is Now Registered, page-20
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