Looks to me very likely that USRM and Comella and gang are in their last gasp....the grim reeper is at the door....
A KEY LONG TIME PARTNER and clinic CO-OWNER just inked and agreed to the United States' PERMANENT INJUNCTION and he's walked away from what the U.S. Attorneys have deemed an "illegal stem cell business"....old Theodore Gradel had enough and signed the CONSENT DECREE....for PERMANENT INJUNCTION...WHAMMO...KAPOW...FULL TILT....
This is B A D....BAD...HUGE BAD for Comella and gang now...it's going to likely seal the deal for the Judge to easily rule in the favor of the DOJ and FDA as Plaintiff(s)...as a key USRM partner and insider just admitted to, and tossed it in by signing what Comella refuses to mediate or accept....
AND...AND...the SAME LAW FIRM representing Comella...their ole "go to firm" in FL (Mitrani)....THEY SIGNED THE PERMANENT INJUNCTION ORDER FOR ole Theodore....THEY WERE HIS LEGAL COUNCIL APPARENTLY....LOL....how the hell much confidence must they have then that Comella and gang can win this now....???? Seems like ZERO to me....
Latest update from highly expert stem cell litigation attorney Richard Jaffe Esq who explains in great detail what has just taken place and it looks GRIM FOR USRM and Comella and gang.....
"US STEM CELL CO-DEFENDANT GRADEL THROWS IN THE TOWEL; MEDIATION FAILS (BIG SURPRISE) March 23, 2019 Richard Jaffe
The consent order of defendant Thomas Gradel has been filed. He is no longer involved with the company and has agreed to a permanent injunction enjoining him basically being in what the FDA considers to be the illegal private stem cell clinic business.
On top of that, the mediation between the FDA and US Stem Cells and its remaining individual defendant, Kristin Comella has failed. No surprise here.
What does that mean?
Well it’s obviously not good news for the Comella or the future of her company. I had thought that the Judge was sending her a message in her denial of the joint motion to cancel mediation, that now would be a good time to fold. If so, the message wasn’t received.
My guess is that the judge will use the consent order as a basis of the summary judgment order she issues against the defendants, meaning the language of the permanent injunction order.
Look to the judge to accept the FDA’s position in toto, now more than ever since one of the two individual defendants has already accepted the FDA’s position. Interestingly, the consent agreement was also signed by the primary or local counsel for all defendants. Technically, it means nothing that the attorneys fighting a case for the two remaining defendants have agreed to the relief requested in the lawsuit for a third defendant. But still . . . . I incorrectly predicted a separate firm would be signing the consent agreement.
The only thing different between this case and the Regenerative Sciences case on which there is binding or almost binding federal circuit court authority is that the Colorado clinic expanded its HCT/P’s, so it didn’t have the same-day surgical procedure exception going for it (21 CFR 1271.15).
But the FDA guidance documents say, imply, or are being interpreted by the FDA to reject the 1271.15 exception to US Stem Cell Clinic because it is not the same HCT/P. In orther words, the HCT/P which is extracted via liposuction (belly fat containing MSC’s) are not the same HCT/P which are reimplanted (some MSC processed SVF). That view is consistent with the FDA’s new “more than minimal manipulation” position in its guidance documents.
So unless this district court has a crystal ball and knows how the Supreme Court is going to rule on a pending case dealing with continued judicial deference to administrative agencies’ interpretations of their own statutes, I am going with the judge giving deference to the FDA’s interpretation of the same-day surgical exception, which knocks US Stem Cell Clinic out of 1271.15 safe harbor land.
The cross motions for summary judgement should be submitted to the court by April 5th. Expect a decision a week or three before the mid May pre trial conference.
Bottom line and practically speaking, Thomas Gradel’s consent agreement agreeing to the relief sought, which was signed-off by counsel of record for all defendants is just one more step to the inevitable, in my view at least.
Rick Jaffe, Esq. "
END QUOTE of attorney and FDA law expert Jaffe....
This POS ALMOST WENT SUB TWO CENTS AGAIN...on Friday and closed WAY BELOW THE 200 DMA which is inverted UNDER THE 50 DMA (death cross territory- the chart is TOTALLY BROKEN)....I'd say it's setting up for the BIG FALL HERE....next support levels are .0175 and then .0150 below that.....
AND we know the post 10-K dilution shares (MILLIONS AGAIN) issued by Tomas to "pay the bills" are getting dumped- who's gonna hold shares in this train wreck when they're for money owed...
IF/WHEN the Judge grants SUMMARY JUDGEMENT and thus PERMANENT INJUNCTION on Comella and U.S. Stem Cell Inc which thus by default means CEO Mike Miguel Tomas too...I'd guess it's time to PULL THE PLUG AND LET THE LAST ONE OUT TURN OFF THE LIGHTS...as it's OVER at the point IMO...
KIT SALES will halt....ALL their whopping three whole clinics will be shuttered and ANYONE WHO'S "in concert" or "does business with them" related to ANYTHING in the PERMANENT INJUNCTION also are cooked and must cease...which means GACP and crew are gonners and who knows who else...
Kristy can work her new "Biohackers aerobics instructor gig" she started now with hubby Shawn Mann and sell that bullshit (LMAO ! WTH is this bullshit "biohackers" LOL??? ).. and Mikey...who knows where he lands....AND the SEC FORMAL INVESTIGATION ain't done yet and any "other" potential federal or other investigations...
LET alone the civil lawsuits still on-going and likely some securities class action firm that will come ambulance chasing to scrape any crumbs since the execs broke FDA laws and all that jazz...
I could see SUB ONE CENT pretty quickly when the house of cards finally goes up in flames in less than 2 months approx....IMO....
The buzzards are circling...the fat lady is warming up and the Feds are about to napalm what's left of the village LOL....up in smoke....
NO WAY IMO...does this end well from here on forward...but hey...it's ONLY LOST 99% OR MORE OF SHAREHOLDER VALUE ANYWAY since Kristy and Mikey took over this disaster in mid 2010....and FOR THAT they got HUGE CASH BONUSES...it's OTC-ville...to the stinky pinky tee....sham-wow special...
HECK YEAH...MASSIVE SHAREHOLDER LOSSES and Tomas is paid like he's some fantasy Fortune 500 CEO as he's off side-gigging for GACP...
WHERE IS 95 YEAR OLD CHAIRMAN OF THE BOARD...the scare crow William P. Murphy...HAS ANYONE SEEN OR HEARD FROM HIM...he's supposedly in charge of this wreck and approves BONUSES TO Tomas and the gang....WTH...????
DOES ANYONE REALLY BELIEVE THEY HAVE A FUNCTIONING and PROPER BOARD OF DIRECTORS at this sham-wow...REALLY? Does Murphy even know or realize his TWO and only "executives" are UNDER FORMAL SEC INVESTIGATION and he doesn't appear to give a rat's behind....does he KNOW ABOUT THE DOJ SUIT LOL ???
ANY real Chairman would have fired Tomas and Comella after about 2 to 3 years MAX at a turn-around...but they got a SEC investigation...a DEPARTMENT OF JUSTICE LAWSUIT...numerous civil suits..99% LOSSES to the common shares...and the "Board" (LMAO !!) gives um LARGE CASH BONUSES at a cash losing money pit dilution and share printing machine.....oh gawd....too damn funny if not so freaking sad...
WARNING...RED ALERT...CLINIC CO-OWNER and USRM PARTNER THEODORE GRADEL SIGNED PERMANENT INJUNCTION CONSENT DECREE....RED ALERT....CIRCLING THE DRAIN....USRM and Comella and gang on POWER FLUSH CYCLE ALERT......
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