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I’ve seen it before, and I predict criminal charges will be filed against Comella and maybe Tomas as well. The FDA will and has many times, sent people to prison for far less. This will not end well for USRM, and all the criminals involved! Be prepared to see USRM close their doors.
Good post. FDA’s going to slam Comella and USRM for their crimes! Not looking good and won’t end well. They may even be prison bound !!
Thank you Hornet! You nailed it. This will not go well for USRM. I fully expect criminal charges are yet to come!
Examples of real consequences for breaking FDA regulations
https://www.fda.gov/ICECI/CriminalInvestigations/ucm123086.htm
Well I keep informing the board so you can be better informed. You should listen to me. Im an expert in drug development/clinical Trials, and as I told you. There is an FDA blacklist, which I posted. Believe me now??
You really don’t have any idea about drug development, the FDA, and how clinical trials are accomplished properly. I sent you the link to the current black list.
The decision has already been made by FDA. SVF is more then minimally manipulated, and considered a drug for that reason. Decision made. No debate left regarding the matter.
There were 4 blind ladies, Not 3.
That will never happen, especially with their FDA violations. KC will never work in research again. I wouldn’t be surprised if the FDA blacklisted her for the multiple violations.
All of USSC’s research was conducted when they were Bioheart. All of that research was focused on MYOBLAST and their Myocath injection catheter, not SVF. I’ve done my homework and I know this to be a fact with 100% certainty. SVF started only after Kristi and Miguel took over. This is all fact.
Who knows if it’s a placebo affect??? That’s the issue. USSC never collected data on patients they treated and never reported SAEs to the FDA. In fact, they never conducted any clinical trials on SVF at all, and certainly no double blind studies. Ktisti’s idea of research was to collate data she found on the internet, and then present it as her own data. This is not how proper clinical data is analyzed, and not the way clinical trials are run anywhere in the world.
I’m an expert in stem cell research/clinical research. I know what I’m talking about. Nice try. There is no big pharma conspiracy.
Nice try....
USSC should have followed the rules. They were a myoblast company before and running proper clinical trials before this SVF bs started. After Kristi and Miguel took over proper research ended. They have conducted no real research on SVF at all.
You know what????
That defense doesn’t fly. Big pharma follows the same rules smal companies have to follow, and are currently conducting the proper clinical trials required by the FDA for stem cells. There is NO big pharma conspiracy going on at all. Do you see big pharma opening stem cell clinics all over the US?
USSC broke the law and will pay dearly when justice is served.
This is nothing but a PR stunt. They have no approval from the FDA for any treatment products, and are being shut down. Soon to be jailbirds. Not looking good for Kristi and Mike.
I know for a fact that wont happen. These lawbreakers will go to jail.
I’ll wait for the courts to expose this. Won’t be long now. Justice is coming
Tic toc, tic toc....................
What part of my posts were not fact based?
No, not at all. In many instances subjects have been harmed from stem cell injections.
Does that include the fake pumpers posting lies on website about how great the company is doing? Anything I’ve seen posted or posted myself has always been based on available public facts and truths. Maybe the CEO and KC should go after themselves for their insanely high salary and bonus’s. And running pump and dump schemes to line their pocket. Under their watch the company has plummeted to almost no vàlue.
Look at old 10Qs, Bioheart had an agreement with a company from Honolulu Hawaii to Sale their adipose derived stem cell automated processing machines. It was a distribution agreement. KC stole that companies technology. She invented nothing she’s self declared expert a robot with no real drug development experience. I hope to see her behind bars soon. I’ll help that process anyway I can. She’s made a mockery of how real companies perform real clinical research. She’ll be a Jailbird soon, I hope
I have news for you. KC didn’t develop any of these products. She stole the prods for extracting Adipose derived stem cells from a company then known as “Bioheart”had a Business agreement to sale their machine that auto processed fat to extract adipose drives stem cells. The company was in Honolulu Hawaii. Kristen stole their technology and process and then pushed Bioheart to break their contract. She is a Fool. She developed nothing, and has hurt and permanently damaged patients with her reckless non scientific ability.
She’s gonna be singing the jailhouse rock soon.
Look on clinicaltrials.gov
You can find her “so-called clinical trials listed there. She listed those studies and many more.
No. USRM doesn’t collect long term safety data on patients. In fact. They lied to patients who were led to believe that were participating in legitimate clinical trials. In reality, no data was collected at all because they were Sham studies. Kristin Comella isn’t even qualified to watch a real clinical trial. She’s singing the jailhouse rock now.
Except for the 4 ladies they blinded, one of which had to have both her eyes removed from her head. I say that’s not a very good safety profile.
Nothing US Stem Cell clinic “supposedly” treats would qualify as life threatening. That law focuses on easier patient access to compassionate use drugs. Look up rules for FDA under compassionate is. This wont save or benefit these criminals currently breaking the law
Regardless of state, the FDA is the ultimate authority for drug approvals.
Medical kits are assembled in a clean room, not a janitor supply store or a garage. Face it.... They broke the law!!!
You’re wrong. The FDA has clearly stated that the stem cell treatments provided by US Stem cell require proper clinical trials and FDA approval
The fact that you believe these charges are nothing and that you accuse the FDA as being corrupt is ridiculous. You obviously have no idea how the FDA works and Kristen Comella’s response to their FDA warning letter was not well done or clever. It was embarrassing. She basically flipped the FDA the bird. This will not end well for US Stem Cell or for mike and Kristen, especially, the latter. They could go to jail!?.
Amazing. This is do much worse then anyone knows. Criminal.