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Yes she lied!!!
Those are legitimate trials except the Angle trial, but Kristi NEVER managed one of them. She only worked in the lab, culturing the Myoblast cells derived from muscle biopsy. Where does it say on that list, that Kristi managed those studies? She was nothing more then a Lab Rat until Tomas came on board. She even orchestrated the removal of Howard Leonardt, Bioheart’s founder’s removal as CEO and from the board. Those studies were managed by legitimate clinical experts. NEVER by Kristi. She is a full of BS. Not a PhD and not the world renowned expert she claims to be. She’s a fraud, and you fell for all her BS!!!
She lied!!!! Yes. She lied. She’s a fraud!!!!
Im not listening to one video of Kristi’s crazy rant! Her view is NOT logical. It’s complete BS and will never hold up in court. The FDA has solid Regulations that specify her method for extracting SVF is classified as a DRUG. End of discussion!!!!
Kristi does not and has not ever managed any clinical trial. She worked in then Bioheart’s Cell culturing lab.
No background managing clinical trials and not one ounce of a medical background. She is nothing more then a lab rat. The FDA requires anyone managing clinical trials be qualified by experience and tracing, plus they need to have a medical background in the disease being studied. Kristi never managed any clinical trials. Especially their legitimate earlier FDA approved clinical studies on Myocell. Her experience is all a lie. Full BS and I’m certain the FDA investigators have figured this out already. Look up the paper published on the MARVEL study. employees of Bioheart are listed as partial authors. You will NOT see Kristi’s name listed anywhere on that paper. That was the last legitimate clinical trial now USRM ever conducted. Her publications are NOT scientific. They’re all jokes. Her Coauthors are not impressive either. They’re all nobodies. No leaders in stem cell therapy listed, ever!!!!
Kristi is NOT a PhD!!!!!!
It’s about protecting a noble profession that follows the FDA regulations and puts patient safety as number one. Kristi has made a mockery out of legitimate science to line her own pockets. She has NOT collected legitimate data on patients and has lowered herself to snake oil salesman. She is NOT a PhD and is NOT qualified to be conducting ANY clinical research on real patients. Kristi is going to jail and so is Miguel. Everyone else in this profession has been required to follow the fDA Regulations and Good Clinical Practices (GCP). Why is Kristi different???? I want to see Kristi punished and behind bars for her reckless behavior. Kristi Broke the regs. She’s not qualified to manage and run clinical trials. You’ve all been fooled, she’s causing harm to patients and investors alike. I won’t stop and I’ll continue to provide my expertise to the Miami office FDA investigators and the attorneys for the 4th blind ladies to ensure she never harms another patients with her fake PhD and sham wow treatments. I’ll do everything to protect my legitimate profession and put a stop to Kristi’s sham wow fake treatments. She will never beat this case, and will go to prison. This case is outrages and it’s akin to a serial killer’s behaviorq. Locking Kristi up is the only way to stop her from harming anyone else!!!!
They won’t prevail. Look at previous cases on the FDA website. fDA investigators are just like the FBI. They have badges. They have the power to enforce the FDA Regulations. This has nothing to do with right to try or if cells are a drug. This is about Kristi’s disregard for and lack of respect for the FDA regulations. She made a mockery of this honorable profession. Flipped off the FDA and she will pay. She Brock so many laws, she will pay big fines and go to jail. You go ahead and live in your fantasy world, but USRM will not prevail. There are consequences for a disregard for the FDA regulations. Kristi is going to jail and USRM will close it’s doors. You wait and see. You have no clue about how the FDA works. Look up warning letters and prosecutions on the FDA website. Kristi and Miguel are not above the law!!! Every company, small and big Pharma alike are required to follow the same rules. No conspiracy here. You’re running nothing more then a pump and dump scam here. You can only pump do much, unless you have $ viagra. Otherwise it’s limp dick hopeless effort!!!!
And what clinic do you think is opening????
Lol. You understand Kristi butchered this four ladies, right? That’s my point. In clinical research the number one principle is to protect patient safety!!!! She didn’t do that!!!
I think buying has dried up.
Lol. NO, you’re wrong!!! It’s been based on actual real science that protects patient safety first and the collection of verified real data. Not fake PhD, Kristi’s reckless snake oil sales!!!!
#kristi heading to prison!!!
This isn’t JUST about the malpractice this is about Kristi’s incompetence and numerous violations of the FDA Regulations and Good Clinical Practices (GCPs).
Do more research, buddy. Many, many, many doctors, nurses, and Fake PhDs have gone to jail for violating FDA rules., NOT just a handful!! That’s a fact!!!! This is all public record, listed on the FDA Website!!!
Ithis only means USRM could gain approval if they conduct real clinical trials for each indication, including a major double blind study!!!
Problem is Kristi is incompetent and USRM has no money or proper staff to conduct FDA Regulated research.
Kristi and Miguel are going to Jail.
First of all, USRM has not treated 100s of thousands of patients.
Second, as noted in the DOJ complaint, Kristi NEVER collected actual follow-up data on patients,, so how could they prove efficacy with out real follow up data?
Third, they never recorded Adverse Events and failed to report Serious Adverse Events to the FDA, so how can they claim these procedures are safe.
So, we’re expected to just take Kristi’s word that these treatments work?
Without real monitoring by a CRA, and collection of real data, Kristi has no credibility and proves she is dangerous and incompetent. Nothing more then a person with a fake PhD experimenting on patients with no credibility or knowledge of drug development. The FDA will make her pay and send her to jail!!!
Her list of FDA violations is huge and shocking, and proves her incompetence. The FDA won’t stop until USRM is out of business and Kristi and Miguel are fully punished!!!
This company is tricking patients to buy their snake oil with ridiculous claims they can cure anything with SVF. Maybe they can inject you and treat your insanity!!
If you think USRM is so awesome, why don’t you pay $7-8k, and let them inject SVF into your eyeballs? Maybe you can get super vision, or go blind and have both your eyeballs removed. Kristi butchered those four ladies. I can’t wait until She goes to prison!!!!!
Because real PhD’s run proper clinical trials, follow the FDA regulations, protect patient safety, and collect Teal follow up data. If you read the complaint then you also noted Kristi never collected any follow up data and failed to report Serious Adverse Events to the FDA as required by regulations. Kristi is NOT a real PhD, she has no idea if her sham treatments worked or harmed anyone because she collected NO actual data on patients! Kristi gives legitimate PhDs and true science a bad name. She is a fool with a fake PhD, and deserves to go to prison!! Real PhDs write and defend dissertations. She is NOT a PhD!!! That’s not bitter!! This is about protecting legitimate scientist who actually follow the rules and protect patients safety!! I know for a fact that Kristi is not qualified or trained to be conducting any clinical trials!!!!
Not one guidance document was cited in the FDA DOJ complaint, only violations of actual FDA regulations are listed! READ THE DAMN COMPLAINT!!!!!
It’s not based on guidance documents. The regulatory violations are spelled out clearly in the DOJ lawsuit. Try reading it and look up the regs, unless you’re not smart enough to read FDA regulations. I’ve done this for a living for 30 years. I know the FDA regs snd I know exactly how the FDA will punish Kristi and Miguel. Guidance documents have NOTHING, ZERO, “0” to do with this case. They will never beat the FDA on this. Many cases have been tried already and people have gone to jail for this same type of case!!!
Wrong again. It will lead to criminal charges. No jury trial will ever happen in this case. The FDA Regulations are clear. They broke the law! Kristi and Miguel will go to jail!!!
A family lawyer has no experience with the FDA at all. That holds no weight. Every expert, including myself, say USRM has no chance of winning this case. They are finished, with criminal charges to follow!!! Kristi and Miguel are headed to Prison!!!
USRM will never win. This has already been tested in courts and someone went to prison for doing and claiming the same as USRM. Look up on the FDA website for prosecutions and blacklisting of people who violate the FDA regulations. They can’t beat the FDA!!! Hornet summed it all up nicely in his post. Their crimes are horrible and will earn them huge fines, blacklisted from conducting further clinical trials, and a long perp walk to prison. These are facts that can be verified on the FDA website. The FDA Criminal investigation office is already involved. This is what led to the DOJ lawsuit. This will never end well for USRM and their company officials, Kristi and Miguel.
I personally know the actual owner of SDF1. It isn’t USRM!!!!
Ok. Good for you. Your pump and dump scam can’t go on forever.
I know my facts. The 10-Q is wrong. They no longer own the rights to SDF1, that’s owned by Cleveland clinic. They also no longer own the rights to their injection catheter which was tied to the initial approval from the FDA for myocell clinical trials. I can’t help that USRM lied in their 10-Q. I know these things to be fact. Ask USRM that question. Why would they lie? Because Kristi and Miguel are both criminals. This is most likely part of what the SEC is investigating them for. Both will be headed to jail for their crimes. You watch. The FDA has the power to send people to jail and has sent people to prison for much less.
Looks to me that buying has dried up!!
Sorry to burst your bubble, but USRM has no rights to SDF1. They lost that deal years ago. SDF1 is 100% owned by Cleveland clinic and that break up did not go well for then Bioheart!!! That is a blatant lie. I know this, personally, to be factual. I’m sure the SEC will/or already has homed in on this lie noted in the 10-Q. You know nothing factual about this company. Clinical trials for Myocell will cost them easy $200 mil, not to mention the staff needed to run the clinical trials. No partnership will happen. USRM is a liability and in a legal mess. Nobody would ever partner with them. If someone was interested in partnering with them they would have received the money years ago. Know your facts!!!
Hornet is 100% correct!!!!
It’s actually 4 blind ladies, not 3. Who know how many other patients she harmed.
Everyone takes campaign donations from numerous businesses.
Senator Grassly has no ties to big Pharma. He’s concerned with public safety.
Wrong again. Kristi’s sham unproven treatment not only caused instant, accelerated, permanent blindness, some of these poor victims had to have there eyeballs completely removed, causing permanent disfigurement. She worsened the condition. She never conducted any pre clinic animals studies and no real clinical trials. this is embarrassing to legitimate scientific study and breaks every standard of medical practice and clinical research principles. She’s selling untested snake oil. If your dr provides an unapproved/unproven treatment or surgery that worsens, your condition or horribly disfigured you, you’d agree and file a malpractice case ASAP. On top of all of this, Kristi BROKE the law. She knew her treatment was considered a drug, due to the processing system, and she knew the digestive enzyme she was using was NOT approved for use in humans! Kristi dug her own grave - Her and her fake PhD! She will be eaten alive in court.
Your wrong. This is about Kristi breaking the law. Big Pharma does not control the FDA.
Not one word I posted is a lie. Let’s see what the court agrees for trial dates tomorrow. Not one word I typed is a lie. It’s all documented by the court motions and real facts. I’ll be in court every day to watch Kristi’s typical behavior. When cornered. She cry’s like a baby looking for sympathy. That act won’t work this time. She dug her own grave. Hedging to jail.
The DOJ lawsuit seeks to prevent them from experimenting on patients any more. That means Miguel and crazy fake PhD Kristi will be on the FDA black list. Next to come will be prison sentences and huge fines. These criminals are done. USRM is dead and not long for business. The fact they still concur to treat patients to this day is even worse. This injunction will hold up in court. Kristi does not have a real PhD, andThe DOJ lawsuit, the 4th blind lady lawsuit and the ongoing SEC investigation/subpoenas shows the government is hitting them from every side. Game over for USRM, Kristi and Miguel. I think you will see an urgency by the Judge tomorrow to push this case through the courts with urgency! This is not good!!!!
The FDA is not squiring baby parts! The FDA does not conduct research. This is an absurd statement!!
10-Q looks bleak! New language added. Kristi and Miguel are running scared from SEC!!!!
DOJ is a certain loss for USRM. When it gets to this point, they loose and it gets worse. Criminal charges to follow. USRM will NOT win against the DOJ. You can thank crazy, reckless, lying, fake PhD, Kristi for her failure to adhere to FDA Regulations, and her lack of respect for the FDA!!!!
Court on Friday. Trial will move forward!!!
Wrong. Comella is not a doctor! Not an MD, and certainly not a REAL PhD. She has zero medical training. She isn’t even trained or authorized to change a diaper in a retirement home. She is a criminal, practicing medicine without a medical license and selling snake oil as a cure for everything. She’s going to Jail!!!! She is a joke to anyone with a real PhD. She gives legitimate science a bad reputation!!! Shameful what she has done. DOJ is stopping her once and for all!!!!
She’s not a PhD. She bought her diploma from an online uncredited college in panama. She is NOT a real PhD. Why else would her attorneys try to block the subpoena of her university records? She didn’t even complete or publish a dissertation. she paid for her degree. It doesn’t mean shit. Her use of that title is a disgrace to real PhDs worldwide!! I worked my ass off to receive mine. Why is she so different?? Maybe she should have taken blue marble’s online MD degree?? That’s even more of a joke!!!