US Stem Cell Inc (USRM)

[Dragon Lady]

MYOCELL CLINICAL TRIALS, SIX PATIENT DEATHS !!

In addition to many, many SERIOUS ADVERSE EVENTS such as V-TACH all requiring the trial patients to be hospitalized.

Like the freaking FDA DOESN'T KNOW THESE FACTS, despite the bad reality that CEO Tomas, SCRUBBED UM, ORWELL STYLE out of all 10-K filings after 2014, SHAZAM, right when they started peddling the CASH-TO-TREAT stem cell "clinic" biz? (Oh, and BLINDING THREE INNOCENT ELDERLY LADIES who "HAD", PAST TENSE, fully functional lives?)


https://www.ipscell.com/wp-content/uploads/2016/11/Amended-Complaint-Bade-Suit.pdf

https://ipscell.com/2016/11/2nd-lawsuit-alleging-a-u-s-stem-cell-clinic-caused-blindness/#

Guess perhaps ole CEO Tomas didn't want any prospective new patients knowing they had some serious problems in the past with their MYOCELL clinical trials, eh, LOL !! He seems to like to REMOVE INFORMATION/FACTS that aren't to his liking? FACEBOOK POST DELETIONS ANYONE- that's what someone else revealed today. Freaking amazing to me.

MARVEL TRIAL: "SERIOUS ADVERSE EVENTS INFO", 10-K ?

In years of prior SEC FILINGS, Bioheart "used to" as in PAST TENSE disclose the proper FACT(s) that their MARVEL and other "heart" trials had SERIOUS ADVERSE EVENTS (as defined by the FDA and trial safety review committee(s), and that Dr Karl Groth PhD CEO, even pulled the plug on the REGEN trial over "patient safety concerns") "adverse events" of such a severity that they required reporting to the FDA, up to and including, SIX PATIENT DEATHS and "irregular heartbeat" problems (V-tach), before the MARVEL trial was SUSPENDED in 2009, for LACK OF FUNDING, never to re-start or progress again. ONLY 20 patients got treated, then the trial STOPPED, SUSPENDED, NEVER PROGRESSED AGAIN TO THIS DAY, SEVEN DAMN YEARS LATER.

But that FACTUAL FULL DISCLOSURE INFO is now missing from the just released March 2017 10-K filing? WHY? WHY WOULD THAT BE? Why did the CEO REMOVE such critical disclosures for current shareholders to read w/o having to dig through years of SEC filings to find such critically important information? WHY? WHY DO THAT????

And most importantly IMO, WHY WAS THE MARVEL TRIAL thus NEVER, EVER, EVER able to attract any "big money" or "smart money" to fund it to completion ?. They, Bioheart (now USRM after the MASSIVE Nov 2015 1-for-1000 REVERSE SPLIT and ole CHANGE THE COMPANY NAME maneuver) instead limped along on the most toxic and worst of desperation financing a company can rely on, all while "supposedly" sitting on some bull crap "$BILLION dollar opportunity"?? BIG MONEY, "smart venture" money during the BIGGEST BULL MARKET IN WORLD HISTORY, it "naturally" finds those "$BILLION DOLLAR" whatever and funds them, but it never was willing to give ole Bioheart another dime after the 2009/2010 period. WHY? WHY WOULD THAT BE?

WHY DID THE CEO REMOVE THE INFO BELOW, FROM ALL SUBSEQUENT SEC FILINGS after approx 2014 ???

https://www.sec.gov/Archives/edgar/data/1388319/000114544314000356/d31044-10k.htm

PAGE 31 (TRY, TRY and find this paragraph in ANY subsequent 10-K or 10-Q filing??? SCRUBBED, like Orwell style, by the pen of CEO Tomas who personally signs every SEC filing. WHY? Why would he remove such important FACTUAL DISCLOSURES from SEC FILINGS?)

"Our product candidates may never be commercialized due to unacceptable side effects and increased mortality that may be associated with such product candidates.

Possible side effects of our product candidates may be serious and life-threatening. A number of participants in our clinical trials of MyoCell have experienced serious adverse events potentially attributable to MyoCell,INCLUDING SIX PATIENT DEATHS and 18 patients experiencing irregular heartbeats. A SERIOUS ADVERSE EVENT is generally an event that results in significant medical consequences, such as hospitalization, disability or death, and must be reported to the FDA. The occurrence of any unacceptable serious adverse events during or after preclinical and clinical testing of our product candidates could temporarily delay or negate the possibility of regulatory approval of our product candidates and adversely affect our business. Both our trials and independent trials have reported the occurrence of irregular heartbeats in treated patients, a significant risk to patient safety. We and our competitors have also, at times, suspended trials studying the effects of myoblasts, at least temporarily, to assess the risk of irregular heartbeats, and it has been reported that one of our competitors studying the effect of myoblast implantation prematurely discontinued a study because of the high incidence of irregular heartbeats.

While we believe irregular heartbeats may be manageable with the use of certain prophylactic measures including an ICD, and antiarrhythmic drug therapy, these risk management techniques may not prove to sufficiently reduce the risk of unacceptable side effects.

Although our early results suggest that patients treated with MyoCell do not face materially different health risks than heart failure patients with similar levels of damage to the heart who have not been treated with MyoCell, we are still in the process of seeking to demonstrate that our product candidates do not pose unacceptable health risks. We have not yet treated a sufficient number of patients to allow us to make a determination that serious unintended consequences will not occur.
"

ALL THAT CRITICAL DISCLOSURE INFO WAS REMOVED FROM ALL SUBSEQUENT 10-K and 10-Q SEC FILINGS? WHY? WHY WOULD THAT BE? MAKES NO SENSE TO ME? CEO had to have done it on purpose IMO.

"Think" the FDA doesn't know about these critical "ADVERSE EVENTS" occurring on such a small trial sample size and that a competitor had to STOP/CANCEL THEIR TRIAL ALL TOGETHER BECAUSE OF SUCH CRITICAL "ADVERSE EVENTS" occurring too ?