Replies to post #92803 on US Stem Cell Inc (USRM)

[Dragon Lady]

Quote LOL, "USRM CEO TOMAS ADDRESSES MISINFORMATION and POTENTIAL MANIPULATION "

LOL....good gawd almighty...too freaking funny to me....

Uh....this POS "company" (a few people in FL) and their big talking CEO are the subject now of TWO, TWO, TWO FEDERAL GOVT AGENCY FORMAL INVESTIGATIONS.....the dude needs a damn mirror if you ask me....cause the one who's slinging misinformation and manipulation and GRADE-A BULL CRAP is HIM.....and now he's got a shiny new SEC SUBPOENA to work with and a FDA open investigation that just got bumped up to THEE VERY, VERY, VERY SENIOR SENATOR from IOWA, thee CHAIRMAN OF THE FREAKING SENATE JUDICIARY COMMITTEE, overseers of the highest offices of LAW ENFORCEMENT and PROSECUTIONS in this nation...all US ATTORNEYS and the FBI and about 50 other 3-ltr govt agencies...

https://www.sec.gov/Archives/edgar/data/1388319/000118518518000705/usstemcell10k123117.htm

JUST FILED SEC 10-K, PAGE 36:

"On or about March 1, 2018, the U.S. Securities and Exchange Commission (“Commission”), Miami Regional Office (“Commission Staff”), served a subpoena upon U.S. Stem Cell, Inc., which seeks production of certain documents and communications including, among other things, minutes and other documents relating to the Company’s board and audit committee meetings, financial statements, and press releases. The Commission Staff is conducting a formal non-public, fact-finding inquiry of U.S. Stem Cell, Inc. This investigation is neither an allegation of wrongdoing nor a finding that any violation of law has occurred. The Company is cooperating with the Commission Staff and has provided, and will continue to provide, information and documents to the Commission Staff.

At this juncture, the Company is not able to predict the duration, scope, results, or consequences of the Commission Staff’s investigation. There can be no assurance that this inquiry will be resolved in a manner that is not adverse to the Company."





It has DAWNED ON THE WORLD THAT USRM and Tomas and Comella are probably in DEEP LEGAL SH%^T if you ask me....from the FDA to the New England Journal Of Medicine to the NY Times to the Washington Post to the Los Angeles Times to NPR...and on and on and on...BLINDING INNOCENT LADIES WHILE INTENTIONALLY MISUSING A FEDERAL MAINTAINED DATABASE, Clinicaltrials.gov and selling what the FDA says is a "NON FDA APPROVED NEW DRUG" w/o proper approvals and TRYING TO IMPEDE A FEDERAL INVESTIGATION..using mis-leading advertising and claims that have "NO KNOWN OR PROVEN SCIENTIFIC EFFICACY" per the FDA Commissioner....just for the "short list" and now the SEC MIAMI OFFICE is about to open up their little gig with a big ole CAN OPENER LABELED, "WHOOP AZZ Inc" on its side....LOL.....

I'd say the dude better start worrying about his own future and serious "legal problems" instead of going around slinging legal threats at others...with his bull crap SLAPP speech BS threats about "slander" and "lies" (LIES, from Tomas, LOL !! KING of the bull crap PR and spin-cycle machine...SEC says lets see your PR..how bout that $5 million from GACP...oh..oh..NEVER HAPPENED...the king of BS hype..oh..oh RMAT..but forgot to mention MULTIPLE FDA 483's and that we were under FDA investigation)....and blah blah blah BLINDING LADIES via literally BLOWING THEIR DAMN EYE BALLS OUT doesn't bother the dude though...THAT is a indicator of some serious "issues" if you ask me...cause that kind of sh%^t can get you a CRIMINAL CHARGE...I'd be a tad worried if it was me personally...IMO....

[Dragon Lady]

ABC NEWS, FDA "CRACK DOWN" on RISKY STEM CLINICS...

Published ABOUT FOUR SHORT MONTHS AGO by one of the nation's largest and most respected news agencies, ABC NEWS. It SPECIFICALLY names "U.S. Stem Cell", this here lil 5 CENT special by name in their article, vetted by their investigative journalist and ABC editors...NOT LOOKING GOOD if you ask me..noper.....

http://abcnews.go.com/Health/wireStory/us-health-agency-crack-risky-stem-cell-offerings-51200556

QUOTE:
"
US HEALTH AGENCY TO CRACK DOWN ON RISKY STEM CELL OFFERINGS

By MATTHEW PERRONE,
AP HEALTH WRITER WASHINGTON — Nov 16, 2017, 4:57 PM ET

U.S. health authorities announced plans Thursday to crack down on doctors pushing stem cell procedures that pose the gravest risks to patients amid an effort to police a burgeoning medical field that previously has received little oversight.

The Food and Drug Administration laid out a strategy for regulating cell-based medicine, including hundreds of private clinics that have opened across the nation in the last decade. Many of the businesses promote stem cell injections for dozens of diseases including arthritis, multiple sclerosis and even Alzheimer's. They can cost $5,000 to $50,000, but there's little research that such procedures are safe or effective.

Researchers for years have called for a crackdown. FDA officials said they will focus their enforcement efforts on "bad actors" who inject stem cell mixtures into the bloodstream, nervous system or eyes. Regulators say those procedures pose the biggest risk to patients.

"We're going to be prioritizing places where we see products — not just being promoted inappropriately — but putting patients at potential risk," FDA Commissioner Scott Gottlieb told reporters on a conference call.

Gottlieb said the agency plans to use discretion in overseeing lower-risk procedures such as injections for achy joints, adding that this approach would allow the agency to get the "most bang for our regulatory buck." He also said the agency needs to be "nimble and creative" in its regulation to encourage legitimate researchers in the field.

Stem cell researcher Paul Knoepfler called the FDA announcement a "positive sign" suggesting many clinics will now need to seek FDA permission before promoting experimental stem cell procedures.

"Now that the FDA's policies are clear, will it back them up with action?" said Knoepfler of the University of California, Davis. "Does it have the resources?"

Stem cells have long been recognized for their ability to reproduce and regenerate tissue. And while emerging research suggests that they will eventually be used to treat a range of debilitating diseases, they are currently only approved for a handful of medical procedures. For instance, adult stem cells from bone marrow transplants have long been used to treat leukemia and other blood diseases.

Most of the new clinics offer adults stem cells isolated from fat. Practitioners collect the fluid from patients via liposuction, treat it with chemicals and then inject it back into the body to treat various conditions.

Three Florida women were left nearly or completely blind by one such fat-based procedure, according to a report published earlier this year in the New England Journal of Medicine. The Florida Medical board previously revoked the license of another stem cell practitioner after two patients died under his care after receiving IV drips of stem cells to the bloodstream.

In August the FDA took action against clinics in Florida and California. The agency issued a warning letter to Sunrise, Florida-based US Stem Cell Clinic for marketing unapproved procedures for heart disease, Parkinson's disease and other conditions. And U.S. marshals, under FDA instructions, seized vials of an unproven vaccine from StemImmune Inc. of San Diego.

The FDA's authority to regulate stem cell procedures is a murky area that has been debated for years.

Typically the agency does not regulate individual doctors or their in-office procedures, focusing instead on products developed by drug and medical device manufacturers. But FDA has asserted its authority in certain cases when doctors begin processing stem cells and marketing them to treat serious diseases.

Guidelines released by the agency Thursday aim to clarify how much processing cells can undergo before triggering FDA regulation.

It also laid out a process for speeding up the review of promising cell and genetic therapies long sought by drug and biotech companies in the field.

"I think it's another example of the FDA supporting innovation while promoting its strong safety standards," said Michael Werner of the Alliance for Regenerative Medicine, which represents drugmakers.
"

END QUOTE.....

That makes HOW MANY ARTICLES/NEWS RELEASES in which they quote the FDA Commissioner Gottlieb or other expert sources, as stating the FDA IS ABOUT TO "CRACK DOWN" bigly on rogue cash-to-treat clinics, and even mention the USCC clinic in Florida BY NAME, and the BLINDED LADIES CASE THEY DID under Comella's supervision, in almost every article? This can't be a good thing or good publicity for this company.


Seems to me there's a big ole consensus of news outlets and science writers that the FDA BULLDOZER is warming up the engine, and is getting ready to PLOW SOME "BAD ACTORS" as Gottlieb calls them...."CLINICS" who operate outside the laws of the FDA as now fully defined in the newly released Guidance Documents....golly...uh..uh...can't be good if you ask me.....

[boardbrain1]

I will be a happy camper to read the update to your post.

GL Longs