US Stem Cell Inc (USRM)

[TruthSpeaker12]

CHECK THIS OUT:

"The draft guidance states that it is possible that the preliminary evidence needed for RMAT designation could come from clinical trials with “appropriately chosen” historical controls, well-designed retrospective studies, or even “clinical case series that provide data systematically collected by treating physicians.” If an RMAT-designated product also receives an accelerated approval based on a surrogate endpoint, FDA could accept “patient registries, or other sources of real world evidence, such as electronic health records” to satisfy post-approval requirements. "

"The interpretation in the draft guidance for gene therapies is significant because there has been uncertainty about the scope of RMAT eligibility. One of the criteria for RMAT eligibility is that the drug must be a “regenerative medicine therapy,” which “includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products.” 21 USC 356(g)(8). Because the term “gene therapy” was not expressly included in the regenerative medicine therapy definition, some feared that gene therapies may have been excluded."


https://www.lexology.com/library/detail.aspx?g=5ac025f7-b03e-41d3-b0a8-30d39fb0aeeb

Can you say....KABOOM!