US Stem Cell Inc (USRM)

[Dragon Lady]

Prior post said: "PRed in last July that it would take about a year to complete the enrollment for phase 3."-

IMO, one should read "PR" VERY carefully. Read it word for word and use "logic" and other means to see what it really says, if read carefully. Here is the "PR" being referred to, in the above quoted statement from the prior person's post:

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

Lets see what it "really" says if read in detail, and under the scrutiny of say an engineering/tech type document, a contract or similar, IMO.

"SUNRISE, FL--(Marketwired - Jul 2, 2013) - Bioheart, Inc. (OTCQB: BHRT) announced today the successful enrollment and randomization of the first patient in the Phase III MIRROR Trial using MyoCell® or muscle derived stem cells.
The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. 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. All patients will receive delivery into the damaged areas of the heart using the MyoCath® Catheter. Data endpoints will include safety, exercise capacity, quality of life, and ejection fraction at 3 months and 6 months. Kristin Comella, Bioheart's Chief Science Officer, said, "We are hoping to achieve results similar to those from the MARVEL trial in which patients improved almost 100 meters over placebo in their exercise capacity test. We believe this therapy can address an unmet need for cardiac patients."
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."

So, what is really in those words- IMO, that "jump out" at me, in my opinion. Thinking like one who'd have to write an engineering or medical spec, or scientific document, or a binding contract for work to be done, just as some examples?

1) "The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America.
"
This, IMO, is a very common technique/writing style that BHRT uses often. What does "up to 35 centers" really mean? It means, that anywhere from ONE, to as many as 35 centers "may" be utilized. Meaning, IMO, if just one site, for whatever reason (the Mexico site where apparently patient #1 was "enrolled"- if that's all it ever amounts to, then that PR is 100% true, as between one and 35 was met. Mathematically it's expressed as 1<center<35.
By contrast, one can look at a Baxter PR about a recent stem cell trial of theirs:
http://www.baxter.com/press_room/press_releases/2012/02_28_12_stem_cell_cmi.html
"The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells".
Notice the difference. It's specific. 50 clinical sites in the United States. Not between one and 50 or "up to" 50. But 50. And one can then go to clinicaltrials.gov and view every last one of those sites, listed out.

2) "The trial is designed to enroll up to 126 patients over a 12 month time period".
Once again, there's the "magic" words "up to" 126 patients. Also "is designed to" - not "it will". Again, from an engineering/mathematics terminology, it again means, that one patient would satisfy that statement, or five or 10 or 50 or who knows? It's vague and non-specific. A more typical wording would be, "A minimum of 90 patients will be enrolled and the maximum will be 126 and it is expected that full enrollment will complete in no longer than 12 months."
If I were to submit an engineering proposal for example- and say a machine or production line, as an example, "will manufacture/handle and produce a throughput of "up to" 10,000 widgets an hour" -it's gonna get flushed in 2 seconds. The customer, or whoever is inking that contract proposal, or whoever will be accepting and doing the "buy-off" of that piece of equipment will immediately ask, "what's the minimum throughput?" One? You need to tell us some specifics, or no dice. Example, "The production line will produce a minimum of 8500 units per hour, and if ramped up to full production using the XYZ option, it will be guaranteed to produce 10,000 units an hour". Something worded like that.
Note the Baxter wording- it's "specific" in that it says "approximately 450". Approximately is a "generally accepted term" in that most can assume it's not going to mean 200 or 100 or 10. But "approximately 450" to any person with common sense, would assume perhaps 400 patients to 475 for example. A "reasonably" known quantity, "close" to 450.

"Up to" IMO, is a very, very carefully worded statement. It means almost nothing IMO. Again, it can mean literally 1 or 5 or 50 or 100? No one, IMO, reading that wording can possibly know what it means. It's not, IMO, at all a common tech/engineering/science style of writing or wording things. It is much more "generally accepted" and "expected" practice IMO, to specifically "bound" or put a "range" on numbers. The study will enroll and test, "A minimum of 100 patients to a maximum of 126 and it will be done at 45 clinical sites or at least 40 sites and as many as 50". That to me, IMO only, is how one would draft that wording.

There needs to be no update on "enrollment" of MIRROR (which of course has not been pulished), IMO, as the "one patient enrolled" update, at one site in Mexico, has met the requirements of the PR. Saying anything more- is only what they choose to disclose or say on their own terms. The "PR" as of now, is "true" as stated, IMO.

Lastly, the last portion of that PR, makes no sense to me whatsoever, IMO?
"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."?

I don't even know what that means? Again, because of very careful wording IMO.
"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 "??


OK, "in part"? Well, what's the "other parts" the FDA stated? Something appears to be missing? Again, IMO, using wording like "in part" is very carefully chosen. It means something else was apparently said or stated by the FDA, but we're not saying or telling what it was or said- that's the way I'd read that, IMO.

Also, then it says because "likely" would interfere? Either it would, or would not, IMO. I'm not use to seeing the FDA, or science wording or engineering wording used as "likely". If they thought it would interfere, IMO, they'd just say so. Also, what sense does it make that "expanded access" (more data, product experience) would interfere in the "clinical" development of Myocell and then the "and/or" wording cause, I guess problems with "marketing it"? Why? It's not even close to being "marketed" yet- so why would that come into play? It, IMO, is just a jumbled statement- confusing and convoluted that really doesn't say a whole lot, at least not a lot that's clear and concise and easy to understand IMHO. I just can't read it, and "get" what it's saying?

They then insert even more vague wording IMO, using the "and/or"? What is it then- one or the other? What is "and/or" in there for?

And finally, and this is the real key one IMO, "while hold items are addressed with the FDA"??
OK, WHAT "hold items" are being addressed with the FDA? Something is "on hold" then obviously? They, IMO, carefully say they "intend to continue to "enroll" in the MIRROR trial "while" these apparent FDA "holds" or whatever are being addressed. "intends", not we will for certain? Notice, IMO, it doesn't say "move forward and conduct the MIRROR trial"- only continue to "enroll" while the FDA issues are apparently "addressed" - as if there is now specific, IMO, "linkage" between the expanded use being denied, some kind of FDA "issues" needing to be addressed and IMO, now apparently somehow tied to MIRROR. That's the way I read that, when I parse it and "try" and break it all down- it's worded in a very confusing, convoluted and "vague" manner IMHO.

When did this occur? What is "on hold" and for "how long"? They could have just written it in plain English IMO, and told shareholders exactly what is "on hold"?

They could have just printed the FDA response for all to read- it's commonly done, I've read other companies put the actual FDA response up for all to read. But that's a very troubling statement IMHO, "on hold by FDA"? What? The trial now is "on hold" per the FDA? Or only "expanded access"- they're lumped all in one, long and convoluted statement IMO, that implies to me a "linkage" that MIRROR "could" somehow be "on hold" related to "something" needing to be "addressed" with the FDA, and only "enrollment" will continue in the meantime, but not necessarily the actual "trial" beginning to be conducted and move forward. "enrollment" and actually "doing the trial" procedures, in my book, are two totally different things, IMO. Step 1 is "enrolling people". Step 2, is they undergo the actual "treatments" and research study process, IMO.

As far as everyone thought, IMO, the trial was "on hold" because of "funding". I'd never caught or seen this wording that something is "on hold" because of the "FDA" and the company is apparently "addressing the on-hold issues with the FDA"? Cause that's what that PR and that particular statement says to me?

Another "vaguely" written PR IMO. It's no wonder, IMO, that nothing more has been said about MIRROR up to this point- beyond that initial PR that "one patient has been enrolled in Mexico"- not in the last 10-K, not in PR, not anywhere that I've seen. I'm not surprised to say the least IMO.

In the most recent 10-K, Dec 31st, 2013, PAGE 2 is the only place a "search" function shows the word "MIRROR" to appear in the entire, 70 plus page document. And this is ALL it said- the word "MIRROR" appearing exactly 2 times:
"We have also initiated the MIRROR trial, which is a Phase III, double-blind placebo controlled study for centers outside the US. The SEISMIC, MYOHEART,MARVEL and MIRROR Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue in the United States from the sale of MyoCell cell-culturing services for treatment of patients by qualified physicians."

That's it- a search showed the word MIRROR appearing nowhere else in that 10-K, other than that "boiler plate" (my opinion) very vague statement (my opinion).

That's my 2 cents. I've seen this many times now, that when one parses their PR, it's often "vague" IMO, and worded very carefully to make them easily "true" or "open ended" w/o anything further ever needing to occur or progress or take place. That's my opinion, and mine only. Make of it whatever one wants.

Good luck trading, buy, sell or whatever only on your own due diligence, my thoughts are just that, mine and mine alone and only opinions as I do my own research.