Wednesday, August 15, 2018 11:15:34 PM
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!!
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