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I’m not wrong. There is no chance USRM will win!!!!
LMFAO. You will see!!!!
Yes I have worked for big pharma and small biotech companies as well. I’ve gained approval for many drugs over my career. I’m retired and in my 50’s. I run my own non profit company now. I’ll never stop advocating for patients and proper research techniques. I’m a real PhD, and I worked hard to earn it. I’m a real scientist, unlike Fake PhD Kristi. All companies, big or small,are expected to follow the same rules!!!! No difference in treatment by the FDA. Big Pharma does not control the FDA and, in fact, fined billions of dollars each year by the fDA for not following the Regs. Why should USRM be any different?
The FDA defines it as a drug, based on the digestive enzyme process they use. This is considered to make the cells more then minimally manipulated by definition in the FDA regulations it makes it a drug. Also, USRMs digestive enzyme is marked not for use in humans. It’s laboratory/animal grade enzyme. They also process the cells in an open process, with no testing for bacterial contamination. They have broken so mane laws it’s not even funny.
And what scientifically led double blind clinical trial are you referring to? Ever hear of the placebo effect??? USRM has not conducted one true clinical trial on SVF. I’d like to see the real data listings, except there are none! This is further proof that Fake PhD Kristi is a fraud!!!!!
Without properly conducted double blind clinical trials there is no way anyone can proclaim SVF is safe or effective. Case closed!!!
Correction.... lose. Auto correct sux!!!!
If they’re the leading Stem cell company, ten explain their lack of ongoing research and their consistent loss of money. They have never ever made money. Every quarter they loose money. Ridiculous!!!!
Lol. No. WRONG. I know the Regs!! This is NOT a guidance document issue, it’s a regulatory violation issue!!!! End of story!!!!
Wrong. Read the Regulations regarding Stem Cells. Not a guidance issue. It’s a Regulatory issue.
Well said Hornet!!! I agree completely!!!
Wrong!!! The regulations clearly define what constitutes a more then minimally manipulated stem cell, making it a drug. USRM’s process for extracting fat with a digestive enzyme is more then minimally manipulated. It’s very clear and FDA regulations are law.
The FDA Regulations are very clear! USRMs process for extracting SVF from fat IS a drug!!! No gray area for interpretation!!!!
Wrong again. The FDA filled the case with the courts seeking permanent injunction and the case went to mediation. The FDA gave them a chance to voluntarily stop and Fake PhD Kristi refused the offer. Big mistake! One person did sign the agreement so the case is active and ongoing. Both sides have requested a summary judgement, and there is no chance USRM will win this case!!!
Wrong. This is not A civil case. This is a criminal case because USRM is violating the law by marketing and distributing an unapproved drug. The FDA is seeking a permanent injunction for breaking the law! Additional criminal charges usually follow the injunction!!! This is how the FDA operates!!!! Learn and do your research!!!!!
LOL!!!! That is not how the FDA operates!! They will never offer a deal to USRM!!!!! They will get a permanent injunction, and then go after them criminally!!!! Fake PhD Kristi and Miguel are both headed to Prison!!!!
Not asinine at all. I know how the FDA operates. Watch and learn, son!!!
Agree completely with you Hornet. So much misleading and uninformed information being peddled on this board. USRM’s days are numbered!!!!fake PhD Kristi and Miguel are heading to prison!!! Criminal charges will follow!!!!
Once again. This has nothing to do with USRM!!!
Thanks Hornet for this fact based post!!!
Grow up. Wake up and understand how politics work. Only the FDA, not senator Grassley, has the authority to approve drugs. Oversight and approval are two different things! If Fake PhD Kristi had followed the rules by opening s proper IND and conducted phase 1-4 clinical trials including a double blind study for SDF, she wouldn’t be in trouble today instead, she will go to prison!!!!
Big Pharma pays the same amount to conduct clinical trials on a drug as small biotech companies do!! Listen and learn!!
Name one industry who doesn’t pay large amounts of money to lobby the federal government. They all do this!!!!
No! Big Pharma pays the same amount to open an IND as does a small biotech company. The costs are equal.
Death vrs blindness. Same thing to me!!!
Total BS. Big Pharma does NOT control the FDA. The FDA imposes huge fines all the time on big Pharma for not following Good Clinical Practices (GCP). Do your research!!!!
Lol. This is for bone marrow transplants used to treat leukemia. Not for stem cells. In no way does this promote stem cells.
Lol. You’ll see. The jokes on you. No chance USRM will win this case.
Lol!! What a joke!! Fake PhD Kristi is NOT a legitimate scientist!!!!
This is the reason why they FDA and all regulatory agencies Around the world must regulate stem cell clinics and treatments It’s a matter of public safety!!!!
https://www.aol.com/article/lifestyle/2019/04/30/2-clients-of-vampire-facial-spa-diagnosed-with-hiv/23719497/
There’s no chance in hell this company will go private. Total BS.
Total BS. Fake PhD Kristi can say whatever she wants but she knows the facts. Her process for SVF extraction meets the FDA’s definition of more then minimally manipulated. SVF is a drug and requires properly ran FDA regulated clinical trials to gain FDA approval. This is all total bullshit!!!!
The conspiracy theories posted here are all bullshit. Big Pharma does NOT influence or control the FDA. This is an issue with USRM breaking the law and selling unapproved drugs , and harming patients. They are snake oil salesmen. The FDA Regs are very clear that USRM’s SVF is considered a drug, because it’s more then minimally manipulated. If they want to seek approval with the FDA for SVF, then they should open an IND and conduct proper clinical trials under the rules of Good Clinical Practice (GCP). That’s the whole issue here. Fake PhD Kristi has no real research to prove efficacy or safety for SVF. She defied the FDA rules and claims some ridiculous bullshit that SVF can cure all diseases, with no real data to back it up. She is a sham, and a criminal, and has harmed multiple patients critically, causing permanent harm to them. The only way this ends is a permanent injunction that closes them down and prevents Fake PhD Kristi from ever conducting clinical research again. Fake PhD Kristi and Dumbass lying Miguel will pay huge fines and go to prison. This company will close its doors, and the stock will be worthless!!!! My advice is get out while you can. I read all these post by people that have no idea how the FDA works or the real power that the FDA has to prosecute people who violate FDA regs. The only person posting on this board that understands the legal trouble this company is in and backs up his posts with REAL facts is Hornet. Nobody else posting here can back up their opinions with real facts!!!!
Watch what happens and learn. Nobody on this site knows anything about pharmaceutical research or stem cell therapy. SDF is a drug because it fail to meet the definitional minimally manipulated stem cells. Refs are regs. Don’t post unless you know what’s you’re talking about!!!
That will never happen. USRM will loose. Fake PhD Kristi will go to prison.
We will see. No chance Fake PhD Kristi will ever win!!!
No chance in hell USRM will ever win this case!!!
Not true. Total lie!!!
This is not a big Pharma conspiracy. This is about Fake PhD Kristi, breaking the law.
What’s fake about hornets post. It’s 100% fact based.