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Re: docprep post# 94060

Wednesday, 05/09/2018 9:43:55 PM

Wednesday, May 09, 2018 9:43:55 PM

Post# of 106837
I doubt you'll find much case law on point and that's the whole idea. There's a genuine legal question to be answered here once and for all.

Does the manipulation of adipose derived autologous stem cell as is performed by USRM clinics enough for it to constitute a "drug" as defined by the regulations and thus bring it under the preview of the FDA?

KC and crew contend that it is not and have been looking for this fight since August of last year with their response to the warning letter. Not sure whether this injunction will be granted but we're definitely set for a legal showdown.

Either way, not good for business in the short term. In the long term, once this issue is resolved and if USRM comes out on top, USRM will cement it's place as the leader in the field. If USRM loses, well, there goes 33% of revenue stream until FDA figures out how to regulate this emerging field.

so, place your bets people.

Go USRM!!!