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Sunday, November 19, 2017 11:11:10 AM
LOL !!
Uh...YOU should read the past news.....
Uh...the ole RMAT hype was around what, like March 2017, something like that???
Well...gee....lets see....WHAT HAPPENED BETWEEN THEN AND NOW, eh????
Uh...MULTIPLE FDA INSPECTIONS of Comella and the USCC clinic biz, that got um SEVERAL rounds of 483 WARNINGS, which Comella DID NOT HEED, which then earned her and USCC and a "cc" copy to USRM, a shiny, brand new, personalized, specific, "FDA WARNING LETTER" in Aug of 2017, LOL !!
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm
Aug 28th, 2017....I'd say that puts the KYBOSH on ole "RMAT" IMO...
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm572416.pdf
Sorta...kinda...like major league changes the ole "RMAT" game thingy...kinda bigly like....
I think..they got about as much chance at the FDA granting um any form of "RMAT" right now, as me winning the Powerball next week....I'd put the odds past outer space astronomical...
I'd say they sorta got "bigger problems" on their hands right now than pursuing freaking "RMAT", let alone they have little cash, almost no employees and are spending about a grand total on avg of $1K a month on "research and development" which is where a company expenses clinical trial costs (LOL ! No, it's a real number, in the latest SEC 10-Q), so I'd say they ain't quite set-up to fund a major FDA quality clinical trial or anything...
Comella in her FDA "rant" video "response" said that "buying too much printer paper and ink" for the FDA to take out REAMS of evidence (copies of documents, CD/DVD burns of computer files, photos, etc) was "financially harming" their lil biz....yepper...it's "on the record" and on video...PRINTER INK and PRINTER PAPER "costs" can apparently break their bank or "harm them financially"...but we're to believe they're gonna go after FDA "RMAT", LOL?????
MAKES NO SENSE TO ME...."RMAT" to me, was nothing but a OTC-ville classic series P&D, and not much more....never even was if you ask me...
Posts are only my amateur opinions, personal views and thoughts. They are not any type of investment advice. Do one's own due diligence.
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