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Dragon Lady

12/15/17 3:19 PM

#85881 RE: NoMoDo #85876

Myocell NO LONGER EVEN UNDER PATENT..uh..

This company isn't up for some supposed "RMAT Approval" nonsense- they're under a FORMAL FDA WARNING LETTER and on-going investigation (no CLOSE OUT to warning issued, so it's wide open) a warning w/ very, very serious allegations and implications. When a company is non-compliant, every application they have goes on hold, for anything they're doing. They got more chance of getting an FDA INJUNCTION filed against um than some freaking "RMAT" fantasy IMO. Court, or being shut-down is where they're headed, not some fantasy approval. Comella strongly downplayed "RMAT" in her recent bloggy tales- and stuck to her "LEGAL DEFENSE FUND" money begging effort and "We're gonna keep treating patients in-clinic" blah, blah which is gonna get the FDA to take the next level ENFORCEMENT ACTION....at this point, I'd put bank on it, as she's not stopped doing what they told her to stop doing, IN THE DAMN FORMAL, SPECIFIC WARNING. The FDA means business when they issue WARNING LETTERS, it's not a freaking joke or some "minor issue" that blows over or magically just goes away. WARNING LETTERS get company's put out of business, it happens all the time.

What the hell is a new drug/treatment worth when ALL key patents have either lapsed, expired or USRM no longer holds the rights to um, as they DID NOT INVENT THE TECHNOLOGY, but only licensed it from others? SAME for key licenses to certain tech they NEED to even make what they call "Myocell" according to their own DAMN SEC FILINGS. They "had" licenses PAST TENSE, but no longer own or hold them anymore. The Myocell trial was SUSPENDED FOR LACK OF FUNDING IN FREAKING 2009, never progressed since.


https://www.sec.gov/Archives/edgar/data/1388319/000118518517000574/usstemcell10k123116.htm

PAGE 8:

"MyoCell is no longer protected by patents, which means that competitors will be free to sell products that incorporate the same or similar technologies that are used in MyoCell without infringing our patent rights. As a result, MyoCell, if approved for use, may be vulnerable to competition
. In addition, many of the patent and patent applications that have been licensed to us that pertain to our other product candidates do not cover certain countries within Europe."

NO LONGER UNDER PATENT. WHAT????? SO WTH does this nano-nano sized company even own as actual "assets" of any real value?

Seems to me nearly their entire supposed "IP PORTFOLIO" is a bunch of LAPSED or no longer existent PATENTS and LAPSED LICENSED etc PER THEIR OWN SEC FILINGS? One of their last actual PATENTS they created, the Myocath COMES OFF PATENT IN Sept 2017, which was LAST MONTH ! OVER….NO MORE…GONE…

What's their actual supposed "IP PORTFOLIO" consist of, when they really didn't invent much of anything, but were just licensing "patent rights" or "rights to use" (licenses) various tech invented by OTHER PEOPLE and OWNED BY OTHER PEOPLE/FIRMS (SDF-1 for example is OWNED BY JUVENTAS, who's been moving ahead w/ it for YEARS, w/o Bioheart, who lost their license to use it) from others, buying rights to now expired patents belonging to others, etc?


http://juventasinc.com/

http://juventasinc.com/news/2016/juventas_Feb3.html

NOTICE THAT: In 2016 Juventas was ENROLLING in a legit clinical trial, THEIR OWN TRIAL, THEIR OWN PATIENTS to test "SDF-1" tech that they own (Not Bioheart/ USRM) and that trial is now in-process, and USRM has nothing to do with it.


https://www.sec.gov/Archives/edgar/data/1388319/000118518517000574/usstemcell10k123116.htm

SEC 10-K, MOST RECENT, PAGE 9:

"MyoCell SDF-1 Patents


To develop our MyoCell SDF-1 product candidate, we rely primarily on patents. We had an agreement to license patents from Juventas. These patents relate to methods of repairing damaged heart tissue by transplanting myoblasts that express SDF-1 and other therapeutic proteins capable of recruiting other stem cells within a patient’s own body to the cell transplant area. We believe we will also need to, among other things, license some additional intellectual property to commercialize MyoCell SDF-1 in the form we believe may prove to be the most safe and/or effective."

HAD, as in PAST TENSE a patent that they had, PAST TENSE "licensed" which is owned by freaking Juventas, NOT Bioheart, as Bioheart did not invent and does not own the IP. It also states they'd NEED TO BUY RIGHTS TO, OR ACQUIRE "OTHER" additional IP, aka patents/licenses to even have a remote chance in H at making what they call their Myocell SDF-1 into a viable product, LOL ! They got nothing looks like to me?

MAKES NO SENSE TO ME, not even 3.33 LOUSY CENTS worth, about what one will get today per share, on the Bid if they sell more than $500 lousy bucks worth of this POS, LOL ?????