US Stem Cell Inc (USRM)

[Dragon Lady]

ANOTHER lawyer opinion: LOOKS GRIM FOR USRM.....

I think I can literally hear the BIG LAW FIRM BILLS SUCKING THE CASH OUT OF THE USRM TINY BANK ACCOUNT....like a SUPER HOOVER SPECIAL...LOL...

AT LEAST TWO MEGA BUCKS LAW FIRMS "ON RETAINER" NOW...and FIVE freaking attorneys so far...but hey, "WE DON'T DO ANYTHING WRONG" according to bloggy tales and Comella videos...I also noticed American Stem Cell Centers Of Excellence recently scrubbed the words "STEM CELL" off their website now too...the Tomas/Comella side-gig show....guess it's too TOXIC...they replaced it with "regenerative" blah blah or whatever....LOL...yeah...that'll fix it and keep the FEDS from finding those clinics and investigating um...LOL...NOT !

This from a REAL STEM CELL SCIENTIST BLOGGER (a very credible one with a REAL PhD by the way)....

https://ipscell.com/2018/05/when-the-fat-stem-cells-hit-the-fire-will-clinics-sued-by-fda-opt-to-stop-soon/

That article it cites a lawyer, a VERY EXPERIENCED ONE who represented a VERY SIMILAR CASE to what USRM is gonna "try" and argue....and it got sunk like a submarine just hit with a nuclear depth charge....

He states how the FEDERAL COURTS DO NOT LIKE TO MEDDLE or even GET INVOLVED WITH FDA OR "other" MAJOR REGULATORY AGENCIES WHO'S POWERS ARE GRANTED BY CONGRESS...thus when the FDA duly warned USRM/Comella MULTIPLE TIMES and they IGNORED THEM ALL (multiple 483 WARNINGS and a FORMAL WARNING LETTER...ALL IGNORED) he believes the court and Judge (Ursula Ungaro is conservative and she's ruled IN FAVOR OF THE FDA before), including where the FDA cited U.S.C. 331 FDA FOOD, DRUG & COSMETIC LAW....the attorney interviewed says his case was almost 10 years ago and the FDA according to him has MORE POWERS/SCOPE over "stem cell" rulings/issues now than ever before...says it's GRIM in his opinion....as the FDA has already won several of these cases with basic variations of the bogus Comella un-argument that, "THE FDA DOESN'T CONTROL US OR HAVE POWER OVER US" blah blah blah has LOST EVERY TIME IT'S BEEN TRIED and it's been in the FEDERAL courts now, several times and never cut the mustard...nope...INJUNCTION in short order IMO...


http://www.isscr.org/docs/default-source/policy-documents/flacase5-10-18.pdf?sfvrsn=2

EXACTLY as they are in the USRM/Comella case) that the FEDERAL courts tend to just rule with the REGULATORY AGENCY and say, "WHO THE HELL ARE WE DO INTERFERE WITH AN AGENCY EMPOWERED BY CONGRESS WHO ARE DOING THEIR JOBS TO THE CODIFIED POWERS AND LAW GRANTED THEM BY CONGRESS?" and they tend to just grant the DOJ/FDA their injunction as long as it's well written and makes sense. This Judge has ruled with the FDA several times prior, including citing U.S.C. 331 JUST AS IS IN THE USRM/Comella case...

http://www.shrimpalliance.com/florida-seafood-company-plead-guilty-to-conspiracy-to-mislabel-shrimp/

https://www.denverpost.com/2010/08/19/fda-slaps-broomfield-stem-cell-clinic-with-injunction-halting-pain-treatment/

https://www.nature.com/news/fda-s-claims-over-stem-cells-upheld-1.11082


THE DOJ/FDA is presenting a SHORT AND SWEET 17 PAGES...the Judge will "get it" in short order IMO....she's gonna say, "SO WHAT'S THE LEGAL CASE HERE" ? The FDA is doing their job, the company and Comella IGNORED THEM and "claims" OUR GOVT AGENCIES DON'T HAVE REGULATORY AUTHORITY...how bout a NICE INJUNCTION SLAPPED ON YA..and it'll be DONE IMO...it's a very straight forward issue according to the attorney who is cited in the stem cell blog. Here's how he explained it:

https://ipscell.com/2018/05/when-the-fat-stem-cells-hit-the-fire-will-clinics-sued-by-fda-opt-to-stop-soon/

QUOTE:

"I asked attorney Andrew S. Ittleman, who was counsel for Regenerative Sciences in the case, for his take on Jaffe’s point and about the relevance of the USA vs. Regenerative Sciences to the new suits:

“Regarding the Regenerative Sciences case, there was never a risk of criminal prosecution. Keep in mind that that case started more than 10 years ago, and at that time there was virtually none of the authority we have today defining the scope of FDA’s jurisdiction or the meaning of the terms in the Part 1271 regulations. That case is still instructive though, mainly because it reveals how unwilling the courts can be to wade into a technical dispute between a federal agency and a regulated business. Keep in mind that the government’s motion for summary judgment was granted and Regenerative’s counterclaims were dismissed before discovery even began! In matters like these, where the case is based on concepts which have been delegated by Congress to FDA and which the government describes as impacting the public health, expect the courts to defer to the agency and keep the litigation brief.
"

NEVER EVEN GOT to the "discovery phase" LOL...Judge just said, "FDA SAYS YOU'RE BREAKING LAWS, THEY WARNED YOU" lets not waste anymore time here...KAWPOW...KABOOOM it was done and over...took a matter of minutes....

http://fidjlaw.com/people/andrew-s-ittleman-esq-c-a-m-s-partner/

The LAWYER IS EXPERIENCED and his case was a MAJOR ONE...very similar to this USRM/Comella FUBAR MESS and it was dispatched by the Federal Judge like a short-fry cook slinging pancakes on a Saturday morning...DONE...SLAPPED UM WITH INJUNCTION w/o hardly reading the case...LOL....FDA is empowered by Congress..what's the "legal" problem(s) here...hey, HERE'S AN INJUNCTION FOR YOU..have a nice day and don't let the court door hit you in the butt on the way out..LOL...

EXPECT THE COURT TO KEEP IT BRIEF IMO and NOT..NOT want to meddle in the FDA's business as EMPOWERED BY CONGRESS...that is what that experienced attorney just said....the FEDERAL COURTS he's saying DO NOT LIKE TO MESS WITH FEDERAL REGULATORY AGENCIES duly empowered BY CONGRESS who warned firms/people fairly, gave um multiple chances etc. JUST SLAP UM WITH THE INJUNCTION AND MOVE ALONG as the courts are clogged and busy..IMO it's why the DOJ wrote a SHORT and SWEET 17 page lawsuit that the Judge can read in 15 minutes and ask, "SO WHAT'S THE PROBLEM, YOU ARE BREAKING FDA LAWS, THE FOOD, DRUG & COSMETIC ACT in numerous ways, HOW BOUT AN INJUNCTION FOR YOU, EH"....that's how I think this goes down..QUICK and to the point....

HOLY COW...NEVER EVEN GOT TO THE "DISCOVERY PHASE" the Federal Judge just slapped the INJUNCTION DOWN...and this attorney said that was 10 yeas ago....and the FDA is even more empowered/CLEARER now on "stem cells" and it's likely the DOJ and this conservative Judge is just gonna SLAP THE INJUNCTION ON UM....

AND...the key to this USRM/Comella injunction...is it is VERY FINELY CRAFTED LEGAL LANGUAGE...17 pages of a NUKE STRIKE that's gonna for all intents and purposes SHUT DOWN LITTLE 3 CENT POS USRM...AND...and...and "ANYONE WHO IS IN CONCERT OR PARTICIPATION OR EMPLOYED" by them....so one can kiss Tomas goodbye in "doing what he does" and their little side-gig special GACP is gonna get a KNOCK-OUT SHUT DOWN PUNCH as it's identical to USRM and U.S. Stem Cell Clinic LLC and is RUN BY Comella/Tomas so it's INSTA-BAKED by a tactical nuke and on and on and on...it's gonna have faaar reaching implications to all the little Tomas/Comella side-gig CASH COWS they "thought" they were gonna get away with via using 100% PRIVATE OWNED LLC's, but it's CLEAR AS THE SUN COMING UP the DOJ/FDA saw right through all that jazz and SPECIFICALLY crafted the lawsuit like a large snare....a fishing net...to GET UM ALL as they say.......

QUOTE FROM THE KEY PORTION OF THE INJUNCTION SUIT:

http://www.isscr.org/docs/default-source/policy-documents/flacase5-10-18.pdf?sfvrsn=2

"Wherefore Plaintiff Prays:

1)That Defendants USSCC (the clinic), US Stem Cell Inc (USRM, this penny stock), Kristin C. Comella and Theordore Gradel, and each of their officers, agents, representatives, employees, attorneys, and all persons in active concert or participation with any of them, be permanently restrained and enjoined from directly or indirectly doing any act with respect to a drug (including a biologic product) that results in the drug being adulterated or misbranded within the meaning of the FDCA, if such act is done while such drug, or one of its components, is held for sale (whether or not the first sale) after shipment in interstate commerce, in violation of 21 U.S.C. 331(K).
"

THAT...is the death blow....IT COVERS EVERYONE connected to Tomas/Comella and U.S. Stem Cell Inc and U.S. Stem Cell Clinic...and ALL "affiliated" etc...they ALL GET SMOKED IF/WHEN THIS JUDGE GRANTS THIS INJUNCTION which IMO ain't gonna take that long....and meanwhile it's BREAKING THE BANK OF CASH POOR USRM as they are fighting so many lawsuits with MEGA BUCKS LAW FIRMS......

AND NOW A FORMAL SEC INVESTIGATION BREATHING DOWN THEIR NECKS....a 2nd 30 MEGATON TACTICAL STRIKE that will be a certain DEATH BLOW IF/WHEN the SEC were to file any FORMAL ACTION against USRM and/or their Sr MGT.....it's grim if you ask me...their GOOSE IS BEING COOKED and it's already PAST WELL DONE IMO...just WHEN now...NOT "if"....and the bottom is $ZERO on this POS IMO...or .0000001 or BK or just the "fade away" and gone...with Comella/Tomas "trying" to operate from their little PRIVATE HELD LLC's and all...just to have the govt hound um and follow those down the same path...that's what I see...