NEWS HITTING: GROUNDBREAKING DEFEAT FOR Comella/USRM....
It's already starting to reach the major science blogs and I'm sure to follow the major news outlets- my guess...it will "break" and go ROUND THE WORLD as this is a landmark case...and the Washington Post and L.A. Times and so many have already covered it....
"Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court
June 3, 2019 Paul Knoepfler
In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc.
The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S.
It’s a big victory for science, regenerative medicine, and patients.
I don’t know if US Stem can continue its fat stem cell injections pending appeal or if the injunction is immediately in force, but I’d guess the latter. The court will issue a separate judgement in favor of the FDA telling us more it seems.
Why is this news such a big deal?
U.S. Stem (including its subsidiary U.S. Stem Cell Clinic and going by the stock symbol USRM) has become one of the most well-known fat stem cell clinics firms at least in part because of the documented loss of vision in some patients.
Its leader Kristin Comella is an outspoken voice for adipose stem cell clinics and for the idea that autologous fat stem cells should not be regulated as drugs by the FDA. She is influential in the stem cell clinic world and other fat stem cell clinics have also taken up similar mantras.
U.S. District Judge Ursula Ungaro apparently saw things differently (rightly, in my view) in ruling for summary judgment for the government. From the court order I linked to at the top of the post is this key section, emphasis mine:
“The Court agrees with the FDA that there is a reasonable likelihood that Defendants will continue to violate the FDCA. Defendants’ violations of the FDCA are not isolated; they have continuously performed the SVF therapy in noncompliance with CGMP as evidenced by the continued violations found in the Form FDA-483’s in 2015 and 2017. D.E. 50-1 ¶¶ 29-30; D.E. 45 ¶¶ 13-17. Moreover, the violations are not merely technical; when confronted with the warning letter and Form FDA-483’s informing them of their noncompliance, Defendants responded not by bringing their practice into conformity with CGMP, but by arguing that they were exempt from FDA regulation. D.E. 45 ¶ 20; D.E. 26 ¶ 52. Lastly, the Defendants’ business will undoubtedly present opportunities to violate the FDCA in the future as there is no indication that they have now complied with CGMP or adequately labelled their product. Defendants offer no challenge to these arguments, and as such, the Court concludes that the FDA is entitled to an injunction under 21 U.S.C. § 332(a).12?
While US Stem might continue as a business and focus on other stem cell-related products such as amniotic or bone marrow cells, I see that as a tough adjustment. Just as likely is the possibility that they will move the fat stem cell offerings outside the U.S.
With this court ruling under its belt, the FDA now has a very strong foundation to go after other risky, non-compliant fat stem cell clinics, with the caveat that USRM is likely to appeal and it’s at least formally possible that USRM could win on appeal even if very unlikely at least in my view. Some physicians who had been offering a la carte unproven and non-FDA approved fat stem cell injections have already stopped doing so over the last 6-12 months so a chilling effect was already evident.
Now comes the arctic blast.
This particular phrase from the court order is the key one, “the Court agrees with the FDA that the SVF is a drug under the FDCA and subject to its adulteration and misbranding provisions.”
More specifically the court decision also does not bode well for the defendants in the other still pending federal lawsuit by the FDA, also focused on fat stem cells.
Overall, again in my opinion this news is positive for both patients and the stem cell field.
More to come as I have time to read the full order, I get opinions from legal experts (which I’m of course not) and we get the additional document from the court. "
END QUOTE.
Amazing update by a key and leading real stem cell scientist - and it says there's going to be MORE TO FOLLOW FROM THE COURT and also we know it's going to be breaking in every major newspaper around the U.S. if not the world and numerous legal experts will comment on it of course...
Looks to me like near CASH BROKE USRM is circling the bowl in the FINAL POWER FLUSH STAGE....as I stated many times prior....THIS IS NOT GOING TO END WELL for Comella and gang.....the legal bills alone and sharp sales decline in the most recent Qtr spell IMMINENT BK IMO...
OR...or just going back to TOXIC DEBT and paying their fat salaries and milking this sham-wow into the SUB PENNY DEATH ZONE for as long as they can now....hoping they don't get criminally charged or SEC charged or whatever is coming next down these bad tracks to nowehreville.....
NY TIMES: STRIKE THREE....YOUR'RE OUT...LMAO...HOLY COW.....
Well..when you get thee NY TIMES....thee Washington Post and thee Los Angeles Times all SMOKING YOUR SORRY AZZ within about 1 hour of each other...I'd say you're just about BAKED AND DONE....well done.....
By tomorrow....EVERY MAJOR NEWS WIRE AROUND THE WORLD will pick this story up and run with it now that it's in the BIG THREE GUNS of news....
USRM revenues already fell off a cliff last Qtr...now they're gonna fall into the abyss of a bottomless TRASH CAN if you ask me...this ain't gonna end pretty....
QUOTE OF NY TIMES ARTICLE SMOKING USRM LIKE BURNING DOWN THE HOUSE:
"F.D.A. Can Act Against Stem Cell Clinic, Judge Rules
A Florida judge says the agency is entitled to an injunction against a stem cell clinic that has blinded patients and challenged the government’s authority to regulate it.
By Denise Grady June 3, 2019
A federal judge on Monday struck a blow against the rapidly growing stem cell industry, ruling for the Food and Drug Administration in its efforts to halt treatments by U.S. Stem Cell, a clinic in Sunrise, Fla., that blinded three patients by injecting a fat extract into their eyes.
The decision does not shut down the clinic but states that the F.D.A. has the authority to regulate it and is entitled to an injunction against it. The judge, Ursula Ungaro of United States District Court for the Southern District of Florida, is expected to issue a further ruling shortly that will specify what action can be taken against the clinic.
U.S. Stem Cell performs liposuction on patients to suck out belly fat, processes the fat to extract what it describes as stem cells and then injects the extract back into patients. It has claimed that the process can treat neurological, autoimmune, orthopedic and degenerative diseases, including Parkinson’s, amyotrophic lateral sclerosis (also known as A.L.S. or Lou Gehrig’s disease), lung disease, heart disease, back trouble, arthritis and other problems.
The clinic is one of hundreds of loosely regulated stem-cell businesses that have sprung up around the country, offering to treat an array of ailments. Some use cells from fat, some use the patient’s own bone marrow or platelets, and some use cord blood or other birth tissue like amniotic membranes.
The industry has grown so fast that the F.D.A. has barely been able to keep up. The agency has focused its efforts on so-called bad actors that have harmed patients or were found to be performing risky procedures that were quite likely to injure someone.
The F.D.A. requested a permanent injunction against U.S. Stem Cell in May 2018, seeking to stop it from marketing stem cell products without F.D.A. approval. The patients who went blind received the injections in 2015, and their cases gained public attention in 2017. Monday’s court ruling does not mention those cases, but it states that multiple inspections had found that the company violated rules for good manufacturing practices and failed to improve even after warnings.
The company and its chief scientific officer, Kristin Comella, argued that because it was treating patients with their own cells, the F.D.A. did not have regulatory authority. The agency disagreed, arguing that the cells were heavily processed and altered from their natural state, making them similar to drugs, which the F.D.A. does regulate. The judge sided with the F.D.A.
U.S. Stem Cell did not immediately respond to a request for comment.
“We’ve been taking action, like this case, against clinics that abuse the trust of patients and endanger their health,” an F.D.A. spokeswoman, Stephanie Caccomo, said in a statement. “We will continue to promote the sound and scientific development of regenerative medicine products, but we will not tolerate those in this field who try to skirt the law and put patients in harm’s way.”
Dr. Scott Gottlieb, who was F.D.A. director when the agency sought the injunction, called the ruling very important and said it provided “a firm legal basis for the F.D.A. to step in and take much more robust action.” He added, “It sends a strong message to people straddling the line that they can’t cross it.”
In her ruling, Judge Ungaro stated, “The Court agrees with the F.D.A. that there is a reasonable likelihood that the Defendants will continue to violate the Food, Drug and Cosmetic Act.”
The F.D.A. has also requested a permanent injunction against another stem cell business, Cell Surgical Network, which is based in Beverly Hills, Calif., and has dozens of affiliates around the country. That case is pending.
"
END QUOTE of NY TIMES version of "WE DONE BE DONE" BY Kristin Comella and gang....LOL.....holy cow.....#HOWBADCANITGET....a hell of a lot worse than this....THIS is just getting started IMO...
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