US Stem Cell Inc (USRM)

[Dragon Lady]

"restarting The Marvel trial yeeeeaaahhhh. "???

Really? When is that supposedly going to happen and funded with what???

Kinda like the ole MIRROR TRIAL, like that?? Let me guess- they'll "enroll ONE PATIENT" in this Marvel trial, then bait the shareholders by putting a one-liner in every SEC filing for the next few yrs that it's "waiting on funding" and then just cancel it in a few yrs, you know, the MIRROR "model" they just used.

Here is the factual history of the MIRROR trial, the much hype ole "Phase 3, FULLY FUNDED BY BIOHEART" (you know, the trial that NEVER ACTUALLY HAPPENED, despite some really "yeaaaaahhhhh" sounding ole PR talk".

1) The original MIRROR PR and the grandiose "claims"

http://www.marketwired.com/press-release/bioheart-announces-phase-iii-mirror-trial-for-myocell-initiated-otcqb-bhrt-1807938.htm

Sounded real impressive. Wow. PHASE 3, "FULLY FUNDED BY BIOHEART" (all except the pesky reality that it never really happened so it couldn't have been you know, "fully funded" - but hey, never let a good sounding PR hype go to waste I guess, what do I know?)

Notice the cool wording like "up to 35 centers" in North America or whatever. That's called legal-eze IMO. You see "up to 35" means anywhere between ONE and 35. Well, the Pr came "true" as ONE CENTER in ole Mexico "enrolled" ONE patient- so technically, they probably legally covered themselves. And the safe harbor jargon probably covers the rest of the reality it never really came true.

2) And look at this "yeeeeaaah" sounding language in that fancy PR- it was even supposed to "compliment" the ole Marvel, the trial that's now supposedly supposed to "re-start" at some point, the ole, "We'll LET YOU KNOW AT A FUTURE DATE POINT". You know what a future date is in legal-eze? It's anytime between the day that PR was issued on Jan 25th, 2015 and basically until FOREVER. FOREVER in the future is a "future date". Again, written in true legal-eze beauty IMO.

From the original MIRROR PR- sure sounded great:
" The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF). Patients are randomized into either the treatment (2/3) or placebo (1/3) arm."

Aaah, but it never "complimented" anything with old Marvel, cause MIRROR never actually happened, now did it? But boy, the ole PR sure sounded good, at least to me.

Now comes the latest PR, the big "update" of all this new stuff, and oops, the ole one liner that quess what, MIRROR IS NO MORE, it's cancelled. No explanation, no why or how, just GONE. Vanished after never even happening in the first place? How can that be? Not like it went 50% of the way and stopped or something, but just cancelled and gone. No how much confidence I have in ole Marvel "re-starting" at some "future date" based on a bunch of hypotheticals needing to happen- per their own PR wording? Me personally- I'd give it less than 10% chance to ever see the light of day IMO. From what happened to MIRROR and how it was pitched and hyped- my confidence in Marvel is close to nil.

Even the most recent 10-Q still had that ole MIRROR phase 3 "carrot" dangling out there- sure sounded good IMO.

Last filed 10-Q, PAGE 29:
"We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds."

So in 1.5 yrs or so they could NEVER FIND OR SECURE FUNDING FOR MIRROR PHASE 3 TRIAL- but one is now to believe Marvel is suddenly going to be "funded"?? LOL, really? Really? Reality, MIRROR just got CANCELLED and never got "funded". But now Marvel supposedly will? Really?

http://finance.yahoo.com/news/bioheart-updates-diversifies-clinical-development-150000986.html

Jan 25th, 2015 PR with a bunch of new grand sounding plans- but stacked full of maybes, we believe, we hope to, the company plans to, if financing blah, blah, if this then that should might happen, we're planning to if, this should maybe happen, etc, etc, etc. Oh, READ THE SAFE HARBOR DISCLAIMER AT BOTTOM.

Oh and MIRROR and ANGEL are gone, cancelled.

From the PR Jan 25th quote:
"The Company has no further plans to advance its ANGEL and MIRROR clinical development programs."

MIRROR, it tells me pretty much all I need to know. My belief in the vague, vast, carefully worded "claims" in this Jan 25 PR, not much, like pretty close to zero. If one parses all the wording in this latest Jan 25th Pr, there's no financial specifics, everything is extremely carefully worded IMO to be vague enough to not be promising or even making concrete any single thing, timeline, date or any other marker that could later be measured or shown to have not come true- cause the PR is so vast and so vague- that if none of it ever comes true- they're 100% covered via the way it's worded, just like the MIRROR PR was structured.

That's my 2 cents. I wouldn't be surprised at all- down the road to see a big PR campaign similar to "ONE PATIENT ENROLLED" or something like that, but this time re-birthing the Marvel trial, and then that will probably be the end of it IMO. Myocell isn't even under patent anymore and all the key licenses related to it have all lapsed- the PR even says they'd have to "get a bunch of stuff back in place" (paraphrasing) before they could even re-start Marvel. That IMO means those lapsed licenses- and I just don't see that happening, let alone why pursue it when it's no longer even got patent protection?

From their own 10-K filing:

PAGE 16:

"Our MyoCell product candidate 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 the form of products that use the same or similar technologies. We have previously licenses certain patents and patent applications relating to our MyoCell product candidate. These licenses have all lapsed as of the date of this report, although we have had discussions with the relevant licensor regarding a potential reinstatement of our rights in such licenses."

Marvel is Myocell- they're one in the same. The Marvel trial is all based on Myocell- the no patent, licenses lapsed platform. So why would it be funded and pursued now? Makes no sense at all to me?

Same 10-K filing PAGE 30:

"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.

And so now Myocell, aka Marvel is all somehow going to be resurrected after basically being parked for about FIVE YEARS NOW, and supposedly "funded" when MIRROR couldn't and didn't get "funded" and all this despite Myocell no longer even being under patent, with lapsed licenses and serious adverse events and all? Really?

I don't get it, not in the slightest? Again, the "WE'LL GIVE YOU MORE INFO AT SOME FUTURE DATE" line in that vast/vague PR is pretty much the key line in the entire PR to me. That's my opinion and feelings on it. Just me.