FDA MAKES IT CLEAR..AGAIN.."SVF"..IS A DRUG..DONE...
AND USRM, Comella, U.S. Stem Cell Clinic LLC....they ain't got a single "FDA APPROVAL" for ANYTHING THEY DO...and the FDA WARNING LETTER they received says just that....it even accuses them of "SELLING AND PROMOTING THE USE OF A NON FDA APPROVED NEW DRUG WITH NO IND OR VALID BIOLOGICS LICENSE ISSUED TO THEM FROM THE FDA" etc..which of course is a VIOLATION OF LAW(s), numerous laws per the FOOD, DRUG and COSMETIC ACT.....
AND... NOW THE UNITES STATES CONGRESS JUST HAMMERED THE NAIL INTO THE COFFIN WITH A BIG OLE HAMMER..."WITH LOVE FROM THE FEDERAL GOVT"...making it 100% CONFIRMED that thee FDA has full control and LAWFUL POWERS to ENFORCE and CONTROL "NEW DRUGS"....and prosecute those who attempt to ILLEGAL PEDDLE NON FDA APPROVED NEW DRUGS...exactly what Comella and USCC and USRM received a FORMAL and SPECIFIC VERY SERIOUS FDA "WARNING LETTER" about already...a WARNING LETTER 100% "live" and "open" and not "closed out", not by a million miles...thee FDA can take "FURTHER ENFORCEMENT ACTION(s)" against Comella/USCC/USRM at ANY TIME w/ no "FURTHER WARNING OR NOTICE NEEDED" and it says so right in the WARNING LETTER...shabang...BOOM BOOM..out go the lights...Congress just said so...LOL.....they sided with FDA Commissioner Gottlieb and crew...
In the recent New England Journal of Medicine article by FDA Commissioner Gottlieb and CBER director Peter Marks, they AGAIN, emphasize that the statements in the new full guidance documents are that "SVF PROCESSED IN ANY WAY, FOR ANY USE OTHER THAN IT'S ORIGINAL FORM" (fat cushioning in a joint, etc NOT freaking ALS, Parkinson's, MS, etc as Comella does daily) IS A NEW and UNAPPROVED FDA REGULATED "DRUG" and will need a FDA "IND" and FDA "NEW BIOLOGICS LIC" etc.
NOTHING has changed per the CNN blah blah article- in fact, the FDA just made it clearer, that "clinics" like USRM and Comella run are IN THE TARGET SITES for the FDA to fully go after for shut-down, it's clear as the sun coming up IMO.
The ONLY companies that Gottlieb is talking about "helping" (or giving a 3 yr compliance window) are LEGIT, FULLY FDA COMPLIANT COMPANIES/ACADEMIA who run and conduct REAL CLINICAL TRIALS while following FDA PROTOCOLS and not "harming patients" and NOT operating under "FDA WARNING LETTER" etc. USRM has almost $ZERO dollars as their R&D budget and conducts NO LEGIT CLINICAL TRIALS to any FDA standards- they're spending "maybe" a $grand a month on R&D, so they ain't conducting any legit clinical trials. JUST PAY-TO-TREAT clinic bull crap, and NOT exempt per "SAME DAY" and "HOMOLOGOUS" according to what the Commissioner just published in the New England Journal.
The Commissioner SPECIFICALLY again mentions bull crap like vast claims of "treating" things like ALS, MS, COPD, CANCER, and every other serious malady known to man via supposed "fat derived SVF" as not being "legit" and not going to be accepted or tolerated by the FDA. NOPER...clear as day to me....the dude is gonna BULLDOZE that nonsense and allow legit FDA standards type "clinical trial research" a faster path forward- which totally excludes USRM then for all intents and purposes IMO.
NO "PAY-TO-TREAT" human experimentation crap is ever gonna be accepted by the FDA IMO....that is NOT what they just described in the New England Journal piece..not by a million miles IMO...
QUOTES from science blogger and stem cell expert (a real expert, not a self proclaimed one) on the new, New England Journal article:
"While this clinic industry is not mentioned specifically in the new NEJM article, it’s there looming large between the lines. The authors do indirectly refer to harms associated with clinics in the US and abroad in this one passage as well as the problem with selling stem cells that have no proven efficacy:
“At the same time, the administration of such stem cells may be associated with serious adverse events.5,6 Even in the absence of serious adverse events, the use of therapies that are of unproven efficacy is a disservice to patients and to public health.” Homologous Use and Minimal Manipulation
Homologous Use and Minimal Manipulation are two of the important elements of how the FDA determines whether a product is a drug or not. In many or even most cases, one might think that stem cell products would have to meet both of these criteria to be a 361 HCT/P not subject to full pre-market drug approval and the new FDA article suggests that too:
“In brief, products that are regulated solely under Section 361 generally are those that do not undergo substantial processing (minimal manipulation), are used in a manner in the recipient that is similar to that in the donor (homologous use), are not combined with another drug or biologic product, and do not have a systemic effect, unless they are designed for autologous transplantation, first- or second-degree–related allogeneic transplantation, or reproductive use (Table 1).”
“The FDA intends to take additional enforcement actions in cases in which it believes unproven products may put patients at risk.”
END QUOTE.
He's stating he also sees CLEARLY that "SVF" will be a "DRUG" to the FDA, especially when pitched and sold for ALS, CANCER as Comella is now trying to do, for MS, COPD, neurological brain stuff, etc ALL of which Comella does, and ALL in the Comella/USRM formal and specific FDA WARNING LETTER they already received. THEIR GOOSE IS BEING COOKED IN THE OVEN AS WE SPEAK IMO...next up..probably FDA INJUNCTION or similar legal action IMO...coming like a sh$%T storm if you ask me....NOTHING CHANGED to the "positive", only just got worse looks like to me...the Commissioner just drew the line in the sand with that New England Journal piece that he doesn't GIVE A RAT's BEHIND ABOUT COMELLA'S "CONSTITUTIONAL RIGHTS TO YOUR CELLS" blah blah bull crap she's been ranting about...the dude appears to me that he doesn't care a ONE BIT what she's been ranting and is gonna ENFORCE THE LAWS....
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