US Stem Cell Inc (USRM)

[Dragon Lady]

Quote LOL, "Loading zone! Once volume comes in you will not touch the 2's ! "

LOADING ZONE??? WHAT???????

Looks more like the trash truck drop-off zone to me, LOL ?????

This thing is getting buried like a shovel ready project.

0.01760 -.0018 (-9.28%)
Real-Time Best Bid & Ask
0.0176 / 0.0178 (145000 x 10000)

SOLID SUB 2 CENT NOW and dropping toward that 100K share Bid down at .0168 and then lower if that gets taken out....heading for the .0150 "hard floor", where the MM's will likely then do a "reset" to that .01, ONE CENT zone if past history is any indicator...

Many still "don't get it" how serious that formal FDA "WARNING LETTER" is, and what it likely means will happen in the future, especially given the so called "response".

Anyone with any FDA regulated/regulatory background would understand it, such as that blogger who is now showing how the "response", is going to be really "no response" at all IMO, when the FDA attorneys read it.

https://www.greyledgebiotech.com/fda-warning-letter-comella-treating-patients-with-fat-tissue-derived-stem-cells-part-three/

That blogger guy IMO, has some sort of FDA "regulatory" experience or background most likely, via the way he writes...and is spot-on correct so far from what I read at a "quick glance" of his little blog commentary...he "gets it", what a formal "FDA WARNING" letter means and how serious the consequences can be, and how they're "normally" dealt with....which ain't happening here so far, not that I can see or tell...???

The FDA didn't ask for a damn debate session or a freaking "petition drive", they expect IMMEDIATE "compliance" by the time they escalate to a "WARNING LETTER" level, and a typical response would usually be pages and pages and pages, a freaking small "book" size document, full of "line items" identifying every issue the FDA raised, followed by DETAILED CORRECTIVE ACTIONS the firm in question will take with expected dates, how each will be addressed to the specific detail, etc.

The only "corrective action" I can see or imagine, for selling a "NON FDA APPROVED NEW DRUG" which is what the FDA states in their "WARNING LETTER" to USSC/Comella, would be to STOP SELLING/PEDDLING that UNAPPROVED DRUG PRODUCT, and stop advertising you can "treat/cure" all the conditions/maladies the FDA named in great detail- such as Parkinson's or ALS or MS or whatever, since the FDA stated, "THERE ARE NO APPROVED OR KNOWN FDA STEM CELL PRODUCTS OR PROCEDURES APPROVED TO TREAT SUCH CONDITIONS", etc.

Thus, unless one stops, they're not in "compliance" that I can see, which IMO, means the next level of escalated FDA "enforcement" is in the on-deck circle. Which my guess, will be fugly-ugly-ville, like a train wreck if you ask me. Bad to worse....A "WARNING LETTER" already clearly states (and it's law) that the FDA needs no further "notice" or even "warning" to take, "FURTHER ACTION(s)" above and beyond the "WARNING LETTER", they can now "enforce" at-will, at any time with no further notice or warning or "announcement" needed...it's part of the WARNING LETTER process, and they state it right in the warning letter....it says the following:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm

"Neither this letter nor the observations noted on the Form FDA 483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility as management to ensure that your firm is in compliance with the FD&C Act, PHS Act, and all applicable regulations.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction."

SEE THAT: "WITHOUT FURTHER NOTICE". They can raid your facility or file a court ordered "injunction" or a dozen other goodies in their "tool box' and they need NO FURTHER NOTICE to do so.....NOT "misinformation" bloggy tales, it's freaking FEDERAL LAW !!

The FDA is a bulldozer, and a ginormous one at that.. and USSC and Comella look like they're parked in a Yugo, right in front of the path of that dozer if you ask me, LOL !!

Only gonna get worse from here....that's all I see...the way I see it...