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NO "BONE MARROW"..."NOTHING NOT FDA APPROVED"...PERIOD....

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Dragon Lady   Monday, 06/10/19 09:14:19 AM
Re: Middleman25 post# 101698
Post # of 101940 
NO "BONE MARROW"..."NOTHING NOT FDA APPROVED"...PERIOD....

READ the freaking words of the court and Judge. "NO SVF" and then adds-in wording, "OR ANYTHING ELSE THAT THE FDA HAS OVERSIGHT OF AND/OR IS NOT FDA APPROVED" blah blah blah.

TOTAL BULLSHIT being pumped by Comella and crew that they're going to somehow now just shift like magic to ILLEGAL use of bone marrow or any other stem cell variant for their hyped up bullshit of supposedly being able to "treat/cure/mitigate" AND DISEASE....

AND.... and especially their massive bullshit of "treating" mankind's most serious maladies such as ALS, Parkinson's, COPD, Traumatic Brain Injury and on and on and on...DONE...OVER ain't gonna happen...

The FDA will have a right to MONITOR...AUDIT...PULL RECORDS and INSPECT anything and everything USRM and their clinics do.....FOREVER......it's a PERMANENT INJUNCTION for a reason....

USRM even has to pre-inform the FDA from now on regarding ANYTHING related to use of a drug....a DRUG is anything used or claimed to treat, cure or mitigate "disease" in humans and /or animals...it was in the FDA/DOJ filing and the Federal judge agreed 100% with that definition as it's codified law....

WHAT IS FDA APPROVED in terms of "stem cells" to treat or cure or mitigate ANY DISEASE in human beings..using ANY TYPE OF STEM CELL...well ALMOST NOTHING yet to this point....only a FEW indication...

Else...one must be conducting a 100% LEGIT FDA CLINICAL TRIAL with a REVIEW BOARD and FDA APPROVED IND FILED AND APPROVED AND MONITORING AND OVERSIGHT and all the rest- and Comella and gang are NEVER going to do that...as they're running the cash-n-carry ole pay-to-treat snake oil sham-wow.....and those ARE NOT LEGIT CLINICAL TRIALS by any stretch of a bad imagination.....

THEY ARE DONE....NO KIT SALES (NON FDA approved medical device with a "for laboratory use ONLY" enzyme in it)...NO "TREATING PEOPLE" for their bullshit wash-list of nearly every serious malady known to mankind- IT ALL STOPS NOW...it stopped THE DAY THEY LOST IN COURT.....

AND.... and Judge Ungaro re-emphasized it in her even allowing them the delay to "try" and negotiate the terms of the INJUNCTION with the FDA...but the FDA is under ZERO obligation or requirement to "negotiate" a damn thing with USRM and said NO to the motion....all the Judge said was "try" and "it would be nice" if mutually "worked out" but if not...then the court decides and they'll side with the FDA as they already did on the Theodore Gradel injunction...who was Comella's partner in law breaking and long time biz partner and clinic co-owner.....

STICK A FORK IN IT...cause they're DONE...their revenues at their lousy THREE CLINICS is down to near ZERO by today...as they can not "treat" a single patient with ANYTHING with "Stem cell" or "NON FDA APPROVED" on it....that's what the Judge ordered....and violation new comes with CRIMINAL CHARGES and contempt....handcuffs and a perp walk.....

HERE IS WHAT THE FDA HAS "APPROVED" for "Treating" using ANY, ANY type or form of "STEM CELLS".....the list is short and involves NOTHING USRM and Comella and gang are doing....NOTHING...

https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies

QUOTE:

"To do your part to stay safe, make sure that any stem cell treatment you are considering is either:

FDA-approved, or;

Being studied under an Investigational New Drug Application (IND), which is a clinical investigation plan submitted and allowed to proceed by the FDA.
"


AND quoting the FDA again:

"About FDA-approved products derived from stem cells

The ONLY stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood.

These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the “hematopoietic” system). These FDA-approved stem cell products are listed on the FDA website. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use."


THAT IS IT. The list is SHORT and to "treat" ANYTHING ELSE IN MAN OR ANIMAL with ANY KIND OF "STEM CELL" bullshit anything...one needs a IND FILED and FDA APPROVED...it's in PLAIN ENGLISH....

USRM biz model is DONE AND OVER....STICK A FORK IN IT...revenues will fall by a dramatic amount (worse than last quarter's DROP OFF A CLIFF THAT ALREADY HAPPENED, READ SEC 10-Q) and VERY RAPIDLY and U.S. Stem Cell Inc Sunrise FL is already near CASH BROKE per their own SEC FILINGS.....

___________________________


Posts are only my amateur opinions, personal views and thoughts. They are not any type of investment advice. Do one's own due diligence.
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