US Stem Cell Inc (USRM)

[Dragon Lady]

Legit companies QUICKLY GOT RMAT..USRM NO, LOL!!

Companies with strong, legit, robust CLINICAL TRIALS done to FDA STANDARDS etc seem to me, sure seem to be doing just fine, dandy and swell with ole RMAT APPROVALS BEING GIVEN ?

Uh, given that long winded and confusing bloggy, about all the supposed woes and "FDA PROBLEMS" and "GEE, WE'RE JUST A SMALL COMPANY" and the "FDA IS INEQUITABLE" and "GEE WE GOTTA WAIT FOR SOME DRAFT GUIDANCE" a blah, blah, blah BS, BS, BS to me-

..then HOW, HOW, HOW have many other companies already SO QUICKLY, SO EASILY RECEIVED FDA RMAT DESIGNATION?

HOW IS THAT POSSIBLE according to Tomas and the bloggy blah, blah tales?

Here is an actual stem cell scientist, a well known one in academia and he blogged about HOW IMPRESSIVE AND QUICKLY THE FDA IS ALREADY GRANTING SO, SO MANY RMAT APPROVALS. But CEO Tomas on a FRIDAY AFTER MARKET CLOSE comes out, w/o the guts to put it in a PUBLIC PR, and whines a cry story about the bad, mean FDA and we gotta wait for some "DRAFT GUIDANCE" and all a blah-blah, cry session?

https://ipscell.com/

He, an actual professor and real stem cell scientist and researcher- he calls it WARP SPEED, the rate the FDA is moving in granting RMAT APPROVALS, 100% in contrast to what Tomas said in the bloggy complaint session, seems to me:

"FDA warp speed RMAT approval nukes stem cell clinic excuses
Posted on June 15, 2017
Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality."

Or this one from same stem cell scientist/blogger:

https://ipscell.com/2017/05/big-change-for-stem-cell-field-with-fda-quickly-issuing-rmats/

NOTICE, he states FDA QUICKLY ISSUING RMAT's, JUST NOT TO USRM I GUESS, LOL !!

"Big change for stem cell field with FDA quickly issuing RMATs
Posted on May 5, 2017
The 21st Century Cures Act has some important regenerative medicine language in it. One part of that was attempting to accelerate FDA review of promising investigation regenerative medicine therapies. The mechanism for this was a new designation called Regenerative Advanced Therapy, now renamed Regenerative Medicine Advanced Therapy (RMAT) Designation."

That is why to me, the bloggy from Tomas is as good as RMAT DENIED IMO. It's just that simple to me. It was a long winded, convoluted, BS "explanation" riddled with bs-speak that goes against massive amounts of other public available info such as NUMEROUS COMPANIES EASILY WINNING RMAT APPROVAL ALREADY, EASILY etc.

Again, to me it's no more complicated that the FDA knowing about the THREE BLIND LADIES and "other" problems at USRM (SIX PATIENT DEATHS IN MYOCELL TRIALS, SERIOUS ADVERSE EVENTS so bad, that then CEO Karl Groth, PhD yanked the funding and shut the trials down in 2009, NEVER TO BE FUNDED OR RE-STARTED AGAIN, EVER !), and stuff like operating NON FDA APPROVED CLINICS, etc.

The other companies that gained RMAT easily, they run highly legit FDA clinical trials, robust trials, with the FDA's approval and monitoring, sticking to trial protocols to the tee, etc.

USRM to me, they went waaay off the rails a long, long time ago and diverged from a legit, FDA level/robust "clinical trials" company for HEART PRODUCTS LIKE MYOCELL, to the ole cash-to-treat Tomas/Comella "new" clinic biz model and basically said, "WE DON'T NEED NO FDA APPROVAL FOR WHAT WE DO, WE DO IT IN-CLINIC AND WE DO IT A LOT" etc. Just watch Comella say it on video, she's on Youtube stating in PLAIN ENGLISH, in a conference that "WHAT WE DO, I GUESS IT'S CONTROVERSIAL AND FALLS IN THE REGULATORY GRAY ZONE" and similar wording. I have the Youtube video, of course. It's all there- she's on camera, like the freaking FDA didn't, or doesn't see that and know all this sh@t already?