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Re: Xpecht post# 96151

Saturday, 06/23/2018 3:44:48 PM

Saturday, June 23, 2018 3:44:48 PM

Post# of 106841
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.