Quote LOL, "RMAT would cause this to rise exponentially, but don't discount the current movement in revenue. Becoming profitable is a very real possibility for the first quarter of 2018.
As that happens, they plan on reinvesting their profits into a larger ownership of clinics. To me that is a winning strategy. Kinda of like the plan of building McDonalds restaurants in every city in the early 80's or Walgreens pharmacies in the 90's through today. This is a new industry and USRM plans on gaining a major competitive foothold by becoming the face of stem cell. "
WHAT????? "RMAT" and Walgreens (LOL !) all while they have a serious, open FDA WARNING LETTER w/ accusations of "MANUFACTURING AND SELLING A NON FDA APPROVED NEW DRUG" meaning ANY "SVF PROCEDURE THEY DO" that's not "cushioning/homologous" per the new guidance documents is ILLEGAL per the FDA. Crystal clear. About 90% of what Comella advertises on their "clinic" website is gonna get um BANNED by the FDA. THERE IS NO WAY FOR THEM TO BE "IN COMPLIANCE" unless they get an IND for every single "indication/malady" they claim to "treat" and do using "SVF", and that ain't NEVER GONNA HAPPEN, LOL ! They'd need about 50 clinical trials running for YEARS w/ pre-clinical data, probably even animal models, etc
And WHERE DID THEY EVER, EVER STATE, "PROFITS WILL GO TO OPENING MORE CLINICS", LOL????????
They do not "own" EVEN ONE CLINIC at this point. USRM, this here penny stock, DOES NOT "OWN" as a company asset, even ONE DAMN CLINIC. They own a 33% portion of the Comella/USCC clinic which is a PRIVATE LLC. Other than that, USRM "owns" NOTHING in terms of supposed "stem cell clinics". That statement made is 100% FALSE.
Tomas stated, and it's IN THEIR SEC FILINGS that any fantasy "profits" where going to be used to , "RE-START AND PAY FOR OUR CLINIC TRIALS" as we have NO FDA APPROVED PRODUCTS TO SELL. That is what the SEC FILINGS SAY. NOTHING about "open more clinics they'd own" like some freaking franchise blah, blah, blah nonsense, LOL !! Just not accurate and NOT what their own CEO and own SEC filings stated and still state TO THIS DAY.
There's a very, very, very real possibility the FDA is going to take further "ENFORCEMENT ACTIONS" against their little clinic biz and probably Comella, as they HAVE NOT STOPPED THE VIOLATIONS NOTED IN THE WARNING LETTER, same as she didn't heed the prior multiple 483 WARNINGS going back to Dec 2015, which GOT THE WARNING LETTER escalation ball rolling. Injunction, court orders to cease and desist are just for starters likely. The FDA works with U.S. Attorneys on enforcement actions and they don't jack around when people ignore them- the FDA Commissioner himself made PERSONAL COMMENTS/COMMENTARY about USCC Clinic/Comella and labeled um as "UNSCRUPULOUS" and "BAD ACTORS" and stated he's formed a special working group/task force to "USE EVERY LEGAL MEANS NECESSARY TO SHUT THESE TYPES OF DANGEROUS CLINICS DOWN". He's said it multiple times now, in multiple major news outlets and SPECIFICALLY connected it to the USCC/Comella/USRM WARNING LETTER event.
Just total nonsense to claim they're even in the hopper for "RMAT" IMO, the FDA knows they're under a FORMAL WARNING LETTER and that has the ability to pretty much prevent ANY PRODUCT they submit from even being reviewed, especially when cGMP violations are part of the WARNING, the damn FDA is HUuuuuuuge on cGMP, it's a company's worst nightmare, that and ILLEGAL/NON FDA APPROVED DRUG SALES in use on humans, and USRM/USCC/Comella just got gob smacked with BOTH, a double sledge hammer.
There's no freaking future McDonalds or Walgreens whatever here, LOL ! Not a chance in H. Even the USRM "stem cell extraction and processing kit" is on the line, as they have NO FDA APPROVALS FOR THAT EITHER, and it's in the prior WARNINGS, just in redacted form if one knows what to look for. FOR LABORATORY USE ONLY is the enzyme, collaganase, they package/brand into their kit- and they never got any FDA approval to use it in a surgical/invasive procedure kit, let alone got the entire "kit" FDA approved as a "MEDICAL DEVICE" which is what it would be- sterility, labeling, dosing, etc. USRM never did any of that.
Total nonsense, NONE of the original statement or claims match their own SEC FILINGS or thee FEDS and the FDA very formal, very specific "WARNING LETTER" etc. Bunch of BS to me w/o any supporting data or facts to back up the statements.....nonsense IMO....
Posts are only my amateur opinions, personal views and thoughts. They are not any type of investment advice. Do one's own due diligence.
