US Stem Cell Inc (USRM)

[Dragon Lady]

"The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell IN PART because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStar™ Catheter to deliver MyoCell to CHF patients."
http://www.marketwired.com/press-release/bioheart-announces-phase-iii-mirror-trial-for-myocell-initiated-otcqb-bhrt-1807938.htm

Those two key words, "IN PART", as well as, (IMO) the extremely important words/wording, "while HOLD ITEMS are addressed with the FDA", (plural case, "ITEMS"), as far as I'm aware, have never been further explained/clarified by Bioheart? "IN PART", IMO, clearly means there is more reason than simply, "The FDA believed that it would have interfered with recruitment of the Marvel trial."

Also, the "plural case" of "HOLD ITEMS" being used, means there are multiple issues/items that apparently need/needed to be addressed to the FDA. I'm not aware of Bioheart ever further explaining/elucidating, what are IMO, very specific, key words, that don't appear to be in the explanation "by accident", IMHO.

The "MIRROR TRIAL" was barely mentioned in the 10-K, end of yr report for 2013. The "MIRROR TRIAL" or the word "MIRROR" did not appear a single time, that I could find using search tools, in this latest 10-Q, SEC report, covering Q-1, 2014.

IMO, there's way more to the story than simply, "The FDA believed that it would have interfered with recruitment of the Marvel trial."

That wording the company used, is very, very specific IMO. Carefully written. "IN PART" is a carefully phrased term IMO. The plural case of "ITEMS" needing to be addressed to the FDA, I'd find hard to believe made it into the company's PR release by accident.

Thus, MIRROR, the "trial" has never been heard of again or updated, as far as I'm aware, since approx. the July 2nd and July 9th, 2013 "PR" and "blog" regarding ONE PATIENT being "enrolled" in Mexico?
http://www.marketwatch.com/story/bioheart-announces-phase-iii-mirror-trial-for-myocell-initiated-2013-07-02

http://stemcellceo.com/wp/bioheart/the-mirror-phase-iii-trial/

Other than those last two "PR" type announcements and the "barely mention" in the 10-K, yr end 2013, I'm not aware of "MIRROR" ever being updated/discussed again, in any formal communication from the company? MIRROR, "the trial", to my knowledge, is also not registered on the clinicaltrials.gov database, and thus there is no formal updates or way to "track" it from there either- where most, "FDA type/quality", formal trials are traditionally and customarily "registered" IMO, per generally accepted industry standards and practices.

And of course, "MARVEL" has gone nowhere, as far as I'm aware, since about 2009 approx. (almost FIVE yrs ago now) according to the 10-K's and various, formal SEC filed documents.

Latest 10-Q, PAGE 26:
" We completed the MyoCell implantation procedure on the first patient in the MARVEL Trial on October 24, 2007. Thus far, 20 patients, including 6 control patients, have been treated. Initial results for the 20 patients were released at the Heart Failure Society of American meeting in September, 2009,"

And, same page, 26:
"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."

If they need to be "reinitiated", then they must be "stopped" as of right now, IMO.