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Sorry to burst your bubble. There has been no win for Comella or USRM. DOJ lawsuit still in progress.
Listen, I know everything about these”matters” I’m an expert in stem cells and drug development. This goose is cooked. They will not win against the FDA. Not a chance in hell.
Honestly, “0” is where it’s going. They’re in such a legal mess, no way they will win!!!
Everything I wrote is true. Is it fake news that the DOJ filed lawsuit to stop USRM from treating patients? Is it fake news that USRM accelerated blinding of 4 patients? Is the SEC investigation fake news? Everything USRM has done is illegal. Kristi and Miguel are both in deep s___!!!
Will never happen. I’ll be there when they haul Kristi and Miguel off to jail. They’re criminals. Going to jail and will never when against the FDA. Kristi made it clear. She flipped off the FDA and has no idea how to work within the FDA requirements. She’s toast. It’s over. Nobody ever wins this kind of attack from the FDA. It’s crystal clear they broke the law. Games up. You will see.
No it won’t!! You’ve been scammed by Kristi!!
Collapse!!!
Actually, she left Tulane under mutual disagreement. Tulane hated her. She had a long history of bad business relationships. She’s been sued numerous times by business associates. She’s no genius. I have an Ivy League education. Ohio state degrees don’t mean shit! She’s dumb as a rock. So dumb, she had to buy her PhD from an unaccredited off shore university. She bought her PhD.
She’s not a real doctor dude. She does lol like a fool. Her only defense for breaking the law is big pharma/government conspiracy theory. She’s an idiot. Dumb as a rock.
What part wasn’t factual. It was all based on fact to me.
One patient success is NEVER enough to approve efficacy for a drug. Could be placebo effect, nothing more. Only a doubling trial will prove the drug works!!!
We will see....
Maybe stem cells are the future, once properly researched and proper clinical trials are completed. Trust me!!!! Big Pharma wouldn’t even consider buying this POS. Too much baggage, too much debt, and big Pharma would never conduct themselves as USRM has. This is an unspeakable bad, illegal, and reckless practice of USRM!!!!!
Not a chance a buyout will happen. Never!!!
A good chance??? Not even a remote chance of judge dismissing this case. It doesn’t happen for crimes like this.
Hornet is 100% correct! This won’t end well for USRM!
Good luck. That won’t happen. No way will ZiSRM prevail. Kristi will go to jail for this. USRM will close. These cases never really go the way you think. The FDA has the authority to enforce this. People have been seriously injured. Kristi has shown no remorse and a compleat did regard for the FDA. She made a huge mistake by taking this stand. A truly experienced regulatory specialist would never have allowed her reckless and illegal research to begin, let alone not respond properly to multiple 483’s and a formal FDA warning letter. She flipped off the FDA and she and USRM will pay significantly. Kristi and mike are headed to jail! They’re totally smoked!!!!
Good Luck with that argument! LOL.
These idiots at USRM took unsafe stem cells with no FDA IND, approvaland injected them to any . Just to make a dollar ore two.
Good Luck with that argument! LOL.
These idiots at USRM even used digestive enzyme, approved for “LAB use only, not for human use
this was sold as part of their Atem cell extraction. kits. This is embarrassing
as part of their in their kits sold by the Comella family
Jeff Sessions knows nothing about the FDA or drug development. Besides, that arrival refers to foods not drugs. Drugs require more regulatory oversight.
You’re wrong! Companies are expected to follow FDA guidance documents also. Especially, those that apply to a companies primary and only product!!!
Since you don’t understand the scientific difference between this product and SDF. I’ll try to keep this response at a 3rd level. USRMs process is open, not closed, increasing the chance of localized, environmental contamination, at numerous steps in the process. They didn’t even use a sterile hood for processing SDF. And finally, a digestive enzyme (A CHEMICAL) is used to release the SVF from the fat tissue. USRM used an enzyme that was cheap, but not approved for human use (Illegal). USRM’s process for isolating SVF from fat is considered excessive manipulation in the production process, which under FDA requirements makes SVF a drug!!! You can’t ignore data in front of your face. No real clinical trials were ever being conducted. This was a sham business, “let’s prey on all the suckers”. Trick them into believing all treatments offered were already previously studied and determined safe, and overseen by/legitimized by the FDA. The only goals Kristi and Miguel had was to line their own pockets, any way possible. Either through exploiting vulnerable desperate patients and/or selling penny stocks to you suckers. They’re going BK, and Kristi’s going to club Fed!!! Good luck!!!
I don’t believe they were ever offered any type of settlement. Cases this big and this serious are never settled by the FDA, and usually proceed on to criminal prosecution. This wont end well for USRM or Kristi. I see jail time and black listing from conducting research moving forward. Potentially, Tomas will get it also. Very strong chance!
Bone marrow is processed differently. SVF requires added enzymes to digest the fat and release stem cells. It’s under a different catagorie. This case is cut and dry. This will be the end of US Stem Cell and will put Kristi and Miguel in jail. This will be fun to watch. Then tell me I know nothing. It’s your money dude!!
Not a chance!!!!!!!!
No! not at all!!! You will see. I suggest you educate yourself on Good Clinical Practices (GCP). That’s really the heart of her criminal behavior. Forget the marketing and selling an unproved drug. Breaking GCP research requirements is enough to do her in anyway.
I work in this industry. I’m also a legitimate PhD and clinical expert in drug development. Perhaps you should consult with a regulatory expert if you don’t believe me. This is wrong on to many levels and Kristi is about to be smacked with a life changing lesson of her own making! 20 years from now she can write a book entitled The All New Orange Is The New Black - Kristi’s Story... I hope she gets substantial prison time!!!!!!
No, not an issue with the FDA. This is about someone without the proper medical/clinical trial training running sham studies to trick patients into believing they are participating in a legitimate clinical trials being properly reviewed and adhering to Good Clinical Practices (GCP) and in partnership with the regulatory authority for the United States (the FDA). Ask any regulatory specialist how to manage an FDA inspection and how to respond to 483s and FDA warning letters. That’s not even close to a proper response. It’s embarrassing and Shameful, showing not one ounce of respect for this important safety net to protect patients.
No, not a well crafted response!!! This was a big mistake on her part. She basically flipped the FDA off! Now she will soon be a jailbird! Well deserved!
Because the FDA has determined it is a DRUG. It’s pretty cut and dry. It’s a drug!!!
That’s not the point. Unless they collect data and scientifically prove safety, we know one thing. It’s not safe to inject SVF into or behind a patient’s. It caused blindness. This is a big mistake. They should have collected all Adverse Events reported by patients, and scientifically shown it’s safe. In drug research you collect every event, even a headache or car accident. Then, you collate the data and provide scientific analysis based on the actual, true number of subjects treated. This is a major reason they will lose the case. FDA’s going to burry them. Soon to be a company where everyone is in jail and doors permanently shut!!
No. Not proven as safe!!!
3 women known to have been blinded? That’s the only Serious Adverse Events we know of, but that’s only because of law suits filed against them. Who knows what other safety issues exist, because they never reported anything to the FDA!! Perfectly safe right? NOT!!!!!!
Sorry, no they don’t. Big pharma has to adhere to the same rules. When they get busted, they pay multi-million dollar fines. Look it up on FDA.org. Small and large companies are held accountable equally.
The FDA has determined that adipose derived stem cells are a drug!! Maybe you missed that part. This is not a medical practice issue like Kristi says. It’s marketing and treating patients with an unapproved DRUG!!!
This is on no related to the FDA case against USSC. This case is about off label marking of s drug that’s already been through initial Phase1-4 clinical trials and has been proven to be safe. USSM is treating patients with a product that the FDA has explicitly stated is a DRUG requiring properly ran clinical trials and FDA approval. USRM has already Harmed multiple patients and using an unapproved Drug and they’ve refused to adhere to the FDA warnings. I suggest, if they want to market this product and treat patients, then they should file an IND with the FDA and run clinical trials tans gain FDA approval.
Leading Stem Cell company? ROTFLMAO!!!!
They don’t even have a clinical staff. No physician as medical director and no property ran clinch last trials managed by real clinical research professionals. They have no money. This is a sham business funded by a penny stock scam. Kristi and Miguel are only lining their own pockets and harming vulnerable patients. This type of operation does not exist in legitimate biotech/pharmaceutical companies. They employ physicians and clinical research professionals. The follow the FDA regulations. Not flip them off with a response to a Serious FDA warning letter. It’s not Done!!!!!
The courts do not determine safety and efficacy of drugs. Only the FDA. This is a straight forward case. The FDA classified adipose derived stem cells as a drug that requires phase 1-4 clinical trials and supporting data for approval. Comella broke the law and seriously injured patients. She didn’t even report Serious Adverse Events (SAEs) to the FDA as required. She’s soon to be a Jail bird. She’s a self appointed expert. Totally fabricated persona. She’s nothing but a lab rat and anybody can do what she does.
Post an example of when the FDA lost.
This is an argument that won’t fly. Like I said, Look up cases on the FDA website that show the FDA enforcement results in other cases.