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Sunday, February 28, 2021 8:31:08 PM
FL court sided with FDA as we know and bans USRM.
It was a shame that Justice Ungaro was not interested in hearing expert testimony from the defense. This makes me suspicious of motives.
FDA may recognize overstepping and try to settle by a compromise than appearing like a total failure so let USRM with their “analogous same day procedures” with a guidance to get their approval for other use cases?
If we fast forward and USRM wins the bench trial the FDA would not have oversight as is the case with any tissue same day autologous tissue transplant procedure. Oversight and guidance would come from state and local authorities (medical board and local government entities).
just focus on that aspect and your business is safe until some national level legislation is defined!
I think Dragon Lady is correct in that legislation governing stem cells will be determined by individual states - not the Feds. This is assuming USRM wins the appeal and then they and or CA Stem Cell win the bench trials.
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