Replies to post #83909 on US Stem Cell Inc (USRM)

[Cdizz123]

I thought they said they would stop putting money and focus less on rmat

[Dragon Lady]

Quote LOL, "You should read the past news. USRM stated that they would stop the move to acquire RMAT until FDA had a clear set of guidelines. Guidelines are set, let's see if USRM makes a statement now about RMAT. With right to try laws in the mix, who knows what will happen. Have to figure out how those laws and how the FDA guidelines affect what happens with stem cell tech going forward. "

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...

[docprep]

RTT doesn't truly maximize stem cell therapy potential as RMAT would.

RTT is only suitable for a narrow portion of people, in a narrow portion of fields where life ending disease treatment is there.

RMAT widens the field substantially allowing not yet FDA approved (fully) treatments that have been shown to be safe, even if not yet proven efficacy, to be actually tested in the real world

This will be the fastest way to accelerate the market, and of course most important to us, skyrocketing the revenue and profits.



I don't believe USRM has really any choice but to pursue RMAT if the guidelines apply to their products and treatments, as it is the quickest way to get to market. I have read the guidelines, and believe it is perfect for USRM and USCC.

I don't believe RTT laws allow for enough instances in time for these treatments to catch on as we would like/want them to.

I also think while RMAT may be expensive, it would certainly be less expensive than fighting the powers that be in trying to prove that its not a "drug".

The pathway guidelines are set, and it would be ignorant by management not to take advantage of this opportunity. Other stem cell companies will, and will leave USRM in the dust if we dont.

I trust KC and MT to do the right thing..