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LMFAO!!! It will never work!!!
No. Educate yourself about real medical/drug research. Its PhD research 101. Everything should evidenced based, with real repeatable data. Fake PhD Kristi never once published or has given proof of real repeatable data. She not out of trouble yet. Expect BR to follow soon.
You’re exactly right!!!! Prison is too good for her though!!!!!
Fake PhD Kristi is no more. Officially resigned from USRM, 1 September. Guess she knows criminal charges are soon to follow and ran scared. She’s not clear from criminal charges at all. It will catch up with her! Karma’s a bitch!
They won’t win. Appeals court will never even take up the case. Judge Ungerio did nothing wrong with making her decision. The appeal will be denied. No court ever goes against the FDA and their expert witnesses! Listen and learn, son!!!!
Totally wrong. All they needed to do was open an IND like every other drug company and conduct proper FDA clinical trials, plus they should have stayed compliant with GCP regulations. This is the problem. They knew it was a drug but never conducted true clinical trials. Fake PhD Kristi flipped off the FDA, and said she didn’t have to follow the rules. That’s why she will go to prison!!!!
This is no longer relevant! FDA already done. Permanent injunction already in place!!!
Criminal Charges Very Much Real Possibility"
"There is a false narrative and more disinformation being spread that criminal charges did not, or can not, or will not ever happen merely because the FDA and DOJ concluded and won, and won big on their CIVIL CASE. (same for SEC investigation which was recently described as "concluded").
Judge Ungaro issued no criminal charges because it was a CIVIL law case, LOL ! CIVIL cases result in sanctions and fines just as Ungaro issued with a legal tool called a Permanent Injunction. This is basic stuff. Civil court and CRIMINAL court are two totally separate entities and have nothing to do with each other.
Um, last time I checked, uh the FDA and the SEC are CIVIL regulatory agencies. They DO NOT file or bring criminal charges or file criminal cases.
IF/WHEN Comella and Tomas and any of their crew get charged criminally it will be from the FBI/DOJ or the FDA's own criminal investigative branch called OCI, "Office of CRIMINAL Investigations" which is totally separate from FDA CIVIL enforcement; when OCI conducts a criminal investigation, it's so secret their own FDA people in the civil division don't even know it's taking place.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/criminal-investigations/about-oci
See that badge on the FDA OCI site? FDA OCI agents carry badges, guns and handcuffs, they're sworn officers of the law with arrest powers- same as FBI or police, etc
That is how a criminal investigation and/or criminal charges will be brought. No one will even know a one year or two year or longer CRIMINAL investigation has been on-going until the day they make their arrests and a public PR is issued by the FBI or DOJ or OCI, etc.
CIVIL versus CRIMINAL, two totally different animals, and nothing has shown that Comella and crew are free and clear of any potential criminal charges "yet", total false narrative and BS.
It's customary with, "THE FED" to let the civil action(s) play-out first before they file any criminal charges, that is how it "works" in almost every case like this. The criminal division can then use the civil investigation and charges as part of the support behind their criminal case, especially when they convene a Grand Jury and then file their case, etc.
Best movie scene ever put to film showing CIVIL vs CRIMINAL. Listen to the FBI Agent talking to Jordan Belfort, aka the Wolf Of Wall Street. He says, "Well Jordan, you know, the SEC is a CIVIL regulatory agency, I'm from the FBI and we pursue CRIMINAL matters".
Bingo, that's the difference. Watch the scene- it's legendary:
https://www.youtube.com/watch?v=z0lByEmGkkU
Shareholders Should Sue USRM
"I'd suggest, shareholders to contact this law firm (Rosen Law, Securities Class Action) and fill-out their online complaint form and file a class action suit against USRM (U.S. Stem Cell Inc, Sunrise Florida, OTC symbol USRM). They never told their shareholders that their product was an illegal drug and not FDA approved. They said just the opposite; their supposed Chief Science Officer Kristin Comella (Fake PhD from Panama on-line diploma mill) she said over and over we are FDA compliant and we need no FDA approvals.
Even after being warned numerous times by the FDA, formally. This was all a lie that USRM was "FDA Compliant" or even conducting legit FDA clinical trials, all a ruse used to sucker-in new shareholders and dilute into oblivion to pay a few key insiders enormous salaries and cash bonuses, as the common stock literally lost 99% or more of its value.
The shareholders have rights to recover losses here via gross negligence, among other SEC violations by Sr Mgt.
To all shareholders: Contact this firm, fill-out the online form and past the text above and then these links below to the news story explaining the lawsuit by the FDA and United States and how they deceived shareholders all these years.
https://www.rosenlegal.com/
Fill out the "Report a Fraud" button, and copy everything above. Then put these links below:
https://www.courtlistener.com/recap/gov.uscourts.flsd.527228/gov.uscourts.flsd.527228.83.0.pdf
https://www.pacermonitor.com/public/case/24475300/United_States_of_America_v_US_Stem_Cell_Clinic,_LLC_et_al
https://www.nytimes.com/2019/06/25/health/stem-cells-fda-injunction.html
https://www.justice.gov/opa/pr/florida-company-barred-using-experimental-stem-cell-drugs-patients
https://www.fda.gov/news-events/press-announcements/statement-stem-cell-clinic-permanent-injunction-and-fdas-ongoing-efforts-protect-patients-risks
https://www.latimes.com/business/hiltzik/la-fi-hiltzik-judge-stem-cells-20190603-story.html
Like I said. USRMs requested changes to the injunction, were all denied. Game over for USRM and Fake PhD Kristi. Criminal investigation to follow!!! Watch and learn!!!
The FDA has shut them down. Permanent injunction was awarded in favor of the FDA in federal court. It’s over.
Completely ridiculous . This is an attempt to reword the injunction, so it reverses the courts decision that SVF is a Drug. There is no way in hell that the judge or the FDA will except these edits by USRM. SVF is a Drug and USRM will never be able to market and treat patients with stem cells unless they notify the FDA and follow the FDA Regs. Fake PhD Kristi just proved even more decisively how unqualified and ignorant she really is.
This is a joke and these edits will never be allowed.
Looks like all the usual pumpers are out again, trying to get the stock above a penny, by twisting and spinning the true facts of this judgement.
The fact is, it’s over for USRM. No fantasy treatments over seas, because as a US company the FDA will still have the power to monitor their activities anywhere in the world.
This POS company is dead and all the pumpers in the world can’t put a positive spin on it.
The stock price will keep falling, and Because of the sub penny stock price, they will never be able to sell enough stock to pay basic expenses, let alone fake PhD Kristi and idiot Miguel’s unjustified inflated salaries. It’s just done. This case proves the FDA has proper jurisdiction to regulate stem cells.
Hornet, PM me your email address. I want to contact you!!! I have additional info to share with you about something else!!
Not a chance in hell! You will see, when the final injunction is released. Fake PhD Kristi and USRMs stem cell days are over. I’m also certain they will receive huge punitive fines and most likely criminal charges. Just wait and see! I’ve been 100% correct about everything regarding the FDA injunction so far. I won’t be wrong with this phase either!!!
This actually makes Fake PhD Kristi look even more like an idiot. She should opt out of the video also. Sound, credible, real, PhDs are all opting out of the video because it’s backed by scam snake oil salesmen, like Fake PhD Kristi. More proof that she is unqualified and not credible!!
Not for long. Just stock manipulators trying to artificially raise the stock price above $1.00.
This company is toast!!!
There is NO new plan. Permanent injunction is exactly what it means, permanent injunction. No more treatments. The final court order will impose punitive fines and criminal charges against Fake PhD Kristi. There is NO positive spin for this. It’s all over!!!!
Wrong! USRM is banned from treating patients with their SDF. Also, they must notify the FDA of any plans to treat patients using any form of stem cell moving Forward. SVF is a Drug and can only be used if USRM actually opens an IND and performs properly monitored GCP compliant clinical trials. What part do you not understand? The fake news being promoted here to try and pump this worthless, POS stock is ridiculous. The company is Dead! Fake PhD Kristi will likely see criminal charges and huge fines next!!! It’s all over!!!!!!
There are no attorneys capable of helping USRM. It’s over, and finished! Next stop will be BR and criminal charges against Fake PhD Kristi. You people live in a fantasy world. All your posts are BS, trying to pump this stock, because with out giving away penny stocks, there is no cash to pay the bills for USRM. They’re over and out!!!
Thank You Hornet for clarifying the results of the injunction!!! You are 100% correct!! All the BS and spin being peddled here is ridiculous! USRM is done!!!! We will wait for criminal charges to come now. Fake PhD Kristi will be punished, and very likely will see prison time!!!
There is nothing positive here. Permanent injunction is not negotiable. It means no more marketing and no more treatments. Why is this so hard to understand??? It’s Over!!!!
Big Pharma will never buy USRM out. This is just step 1. Criminal charges to follow for Fake PhD Kristi. If you read the injunction , USRM must inform the FDA of any research or treatments they use, dabbling in any form of stem cell therapy. No off shore treatments and certainly no treatments on an Indian reservation. You’re all trying to spin this with hope, but USRM’s game is over. How can they continue to pay their bills by giving away sub .01 share price. This is all ridiculous
Ok. I will say it now. I told you all there was no way USRM could beat the FDA. Next will come criminal charges. If you all understood anything about drug development, you would have listened to me. I get the last laugh. It will be a stock free fall tomorrow. Game over. Fake PhD Kristi will go to prison. It’s over for her!!!
These are not “Formal” research studies. None involved an IRB, there was no independent data monitoring, and no compliance with FDA regulations/GCP. This is a joke and not scientific at all. More of Fake PhD Kristi Sham WOW bullshit!!!!
You obviously don’t understand the FDA regulations and the FDA’s power for enforcing compliance wait and learn! Not one expert agrees with you. Fake PhD Kristi is headed to prison. You’ll see!!!
Tick Tock Tick Tock.
What waiver? This is about an FDA case. No waiver has been provided by the FDA!!!
Begaining of the end. Fake PhD Kristi is headed to prison, company is going down. BR is next.
Fake PhD Kristi will go to prison. Wait and see!!!
I totally agree!!!!
Total BS. An article written by Fake PhD Kristi who has no legitimate clinical trials to back up her claims of efficacy safety using SVF!!!!!!
This is not about guidance documents. This is about breaking FDA Regulations Stop spinning this!!!
What does????
This nonsense misinformation is constantly pedaled here. Read the FDA Regs and learn.
Wrong!!! This is how every FDA case proceeds. Try looking at recent criminal prosecutions by the FDA on their website. Did Miguel tell you to post this BS????
Federal court and decisions take time. Sometimes things move more slowly. Means nothing. This case is cut and dry. USRM will not prevail. No way in hell!!!
Cigarettes are not meant to treat illness. This is a leftover historic past of the US. Farming tobacco. It’s not regulated the same way. I wish it was illegal though. It’s a disgusting habit and a major public health issue. It should be outlawed!!!
No. ISRM has never conducted a real clinical trial on SVF. They can make no claims of safety or efficacy!!! No scientific proof. It’s embarrassing!!!
Wrong. I have developed multiple drugs for rare disease, heart failure, Parkinson’s disease, diabetes, and many many more. All have a very strong safety profile and none of them caused death!
None of your business!!! Educate yourself by going to the FDA Website and read the FDA Regs governing drug development, also read Good Clinical Practice (GCP)
Look up and read all the latest FDA warning letters then review the FDA criminal convictions. That will tell you everything you need to know.
Wrong. It’s with the judge. Both sides requested summary judgement!!!! Total misinformation!!!
I don’t need to!!!!