Quote LOL, "But the theory falls apart when the company announced in late June or July or even August (who really cares when) that they still plan on pursuing RMAT but only after the FDA creates guidelines. The FDA just released those guidelines and USRM followed through on their promise. They even hired a law firm that specializes in working with the FDA to make things happen. WOOHOO!!! "
Uh...THE ENTIRE "RMAT" ANYTHING "theory" is blown to smitherines because in ON AUG 24th, 2017, THEY RECEIVED A VERY FORMAL, VERY SERIOUS, VERY SPECIFIC FDA "WARNING LETTER" enforcement action. "RMAT" from the FDA now?
AND, thee FDA commissioner himself, labeled them as "UNSCRUPULOUS" and "BAD ACTORS" and stated he's formed a special "task force/working group" SPECIFICALLY to "USE EVERY LEGAL MEANS POSSIBLE" to "go after" companies such as USRM and their "clinic" biz, who Gottlieb himself described in the most scathing of terms.
The chance of the FDA engaging this company in "RMAT" anything, IMO, is past lotto odds.
The next level "ENFORCEMENT ACTION" typically involves the DOJ, as in U.S. attorneys, probably some sort of court-ordered injunction, and up to possibly even criminal charges can be filed in these types of situations, or at best, "plea" deals worked out.
They had MULTIPLE 483 WARNINGS going back to at least late 2015 that they DID NOT HEED, and thus were re-inspected again in April/May 2017, and by Aug the FDA issued the WARNING LETTER, which takes FDA internal lawyer review and a whole host of procedural steps, as it's a very, very serious "action" by the Federal government. The allegations made in that WARNING LETTER are as serious as they get- mainly, "SALES OF A NON FDA APPROVED NEW DRUG" that caused grave harm to at least THREE INNOCENT LADIES, something the FDA commissioner himself, ALSO ADDED PERSONAL COMMENTARY about, several times now.
"RMAT" thus to me, is a CLASSIC P&D, as it's beyond a stretch to me to even remotely believe the FDA is going to engage the "BAD ACTORS" with a live and VERY MUCH OPEN/ACTIVE "WARNING LETTER", for which Comella has NOT stopped "treating" human patients using the very methods and for the very maladies described in great, great detail in that letter- which means the FDA can do any number of further "ENFORCEMENT ACTIONS" (injunction, basically a cease and desist, seizure of product, and up to even potential criminal filings) AT ANY MOMENT, NO FURTHER NOTICE NEED BE GIVEN, again ALL EXPLAINED IN GREAT DETAIL IN SAID "WARNING LETTER" action.....
ANYONE with any FDA "regulated/regulatory" background knows that Warning Letters are deadly serious, they're typically THEE LAST STEP...the LAST DITCH ATTEMPT by the FDA to get a firm/person to STOP THE VIOLATING, else they drop the big hammer...the nuke level stuff, the DOJ stuff...and Comella hasn't stopped a damn thing at the clinic, the USCC website itself advertises STILL, for every malady the FDA already told her to STOP "TREATING"....
"RMAT" thus = P&D to me, it's not complicated, not even in the slightest....it's OTC-ville classic stuff to me...textbook style....
Posts are only my amateur opinions, personal views and thoughts. They are not any type of investment advice. Do one's own due diligence.
AI
