FDA = DOJ_ATTORNEYS_WHEN_THEY_PURSUE_ROGUE_"STEM_CELL"_PLAYERS !
Malpractice insurance doesn't do a damn thing when the FEDS and Department Of Justice attorneys are busting a stem cell "clinic" or physician/owner operator of same or similar LMAO !!
Messing with bogus "stem cell cures" = FDA = DOJ who is their "enforcement arm" + the FDA OCI (office of criminal investigations)
An IND = worth not much LOL ! They can be "filed" a dime a dozen, so what ?????
"Animal models" = even less, as in nearly worthtless. The number of drug/FDA approved products that ever make it from an "animal model" to FDA APPROVAL = less than 2%, thems the facts and all PhD's and/or M.D.'s who've ever run a FDA approved series of clinical trials are well, well versed in this reality.
An "IND" filing = STEP ONE in an approx 10 YEAR process that costs "on average" about $1 BILLION DOLLARS as of 2021 to complete Phase I, Phase II and then Phase III clinical trials WITH FDA APPROVAL needed at each step and then final vetting and "possible" FDA APPROVAL to a marketable product/drug for use on human patients.
CELZ-a-CON had (past tense) approx $38K to their name and on their balance sheet as of their last SEC 10-Q filing LMFAO !! My local immigrant owned donut store dude makes more cash in 2 months than CELZ-a-CON does by never ending use of toxic debt and share dilution LOL !
CELZ-a-CON has no facilities, no employees, no medical research labs of any kind, essentially no employees - and especially no decent size medical research team with all required staffing etc. It's VAPOR-WARE Inc working from a residential house in freaking bum-F AZ !
The FDA is no longer jacking around with "stem cells" and these nano-nano cap "companies" (a few dudes in a rented house in Arizona) proclaiming miracle cures and "Solutions to the $30 BILLION dollar stroke market" blah blah blah BS !!
FDA is now also using the FTC (Federal Trade Commission) to pop these scams with FALSE ADVERTISING CLAIMS FEDERAL Statutes also -
"FTC Stops Deceptive Health Claims by a Stem Cell Therapy Clinic October 18, 2018
Defendants lacked scientific evidence that their “amniotic stem cell therapy” could treat or cure serious diseases, including Parkinson’s, macular degeneration, cerebral palsy, and autism"
That is THEE FEDS one is messing with there - unlimited budgets and the DEPARTMENT OF JUSTICE does their "legal work" for them = good luck to CELZ-a-CON cause they're gonna need it IMO LOL !!