This isn’t a slam dunk for either side which is evident in the length of time this is and potentially will take to resolve. Much education and clarity is needed in order to make progress here. IMO the Stromal Vascular Fraction (SVF) adipose tissue for treatments/therapy hold a lot of promise due to abundant amount cells extracted through a non-invasive outpatient procedure. This almost seems too good to be true...One can liposuction fat, centrifuge the fat to isolate the stem cells, and then simply inject into the same patient? Most people have no clue what an SVF or Adipose tissue is, however there are thousands of clinics both domestic and international which are offering these therapies. Some of them like USRM are generating record breaking revenues. Treatments once only the rich could afford and travel outside of the country to get are now in a price range more people seem to be able to afford. What is the demand going to look like when “Adipose Tissue” and its benefits become well known?
Now the big question here is, does taking the fat tissue and processing it through centrifuge and enzymes warrant the adipose tissue for cells to be characterized as a “Drug” and in turn be under FSA regulation. The FDA has guidance documents which say their opinion is that these treatments should fall under the “drug” category however this is only guidance. The FDA director Gotlieb
Said himself we are in a “paradigm shift” in modern medicine with regenerative stem cell therapy, however it seems they want more control over this based on the recent lawsuit. Through mediation we may find out what is the fair approach here, otherwise it would go to trial of our peers. Ask yourself this....if you took random people off the street and asked them “should their own cells in their bodies be regulated by the FDA”. IMO the overwhelming response would be a big NO.
I think the DOJ/FDA realize if this goes to trial USRM’s chances of outright winning are extremely high. IMO the DOJ/FDA will take a “meet in the middle approach” in mediation to try and get some semblance of control/oversight. If not and USRM holds their ground, then good for USRM and people’s right to harness their own bodies to heal. I like their chances in a trial of peers. Downside here is 100% if USRM is shut down but there is infinite upside. Bottom line...if there was a legal way to shut them down it would have already happened, this is a control/oversight issue and one would be foolish to not think Big Pharma may be playing a role in holding these ground breaking therapies back as long as they can.
All just my opinion here folks
