US Stem Cell Inc (USRM)

[Dragon Lady]

What does it mean? Just what it says. Read it carefully:

""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.""

Thus, IMO, that "PR" is now true, if nothing more was ever said about it or MIRROR again. ONE patient was "enrolled" (I suppose they need to be "treated" to "technically" make it 100% true- as "enrolling" means no "trial" has actually been "conducted" yet?), but when one ads in those two, very, very key, very important IMO, "little" words "up to"- it means, in pure English, engineering or similar terms, anywhere from 1 to 35 "centers" and between 1 and 126 "patients", IMO. That's all it says and nothing more. "up to", being inserted into those sentences changes their meaning in huge ways, IMO.

Those words, "up to", change the meaning entirely. They're not in there by accident IMO. Again, IMO, I'm never used to seeing science/engineering/contract specific type documents worded that way. Especially in regards to a medical trial "sample size"?

It makes the range "unbounded" essentially in a legal, mathematical, probability/stats terminology.

Define "up to" 35 centers? What does that even mean? That means 1, 5, 10, 15, 20, 30, 35? What does it mean? A "proper" way to state it IMO is, "The study will take place AT 35 centers." (PERIOD- now you know it's 35). Or if you need some "wiggle" room, "The study will take place at, from between 30 centers minimum to a total of as many as 35 centers, if maximum enrollment and maximum sampling size is used and achieved." (something to that effect). Now it's a finite, definitive, bounded description.

Else, via using "up to", it remains vague, and undefinable IMO.

When one "designs" a study- the sample size, using very specific tools, has to already be known, to make it a truly credible study. There are very, very specific probability and statistics mathematics that must be used, in order to insure that the study outcome will be of any credible accuracy or provide any outcome of any meaning. And step one, typically is determining of the "sample size". It does not come out as a number, that can be worded as "up to" typically. It has a minimum number, an absolute minimum that must be met, or the study outcome will be garbage essentially. It's way to complex to go into the sample size calculation here- it's a lot of math/probability and statistics, but I've never known of it being able to be stated in terms such as "up to". There would have to be a fixed, already determined, lower range, minimum number for the sample size. Here, read this- it's complex, but it gives the jest on determination of minimum "sample size" as being one of the most critical steps in designing a "good" and "credible" study- again, I have no idea how the wording "up to" could then be used, IMO:
http://ndt.oxfordjournals.org/content/25/5/1388.long

"In conclusion, the calculation of the sample size is one of the first and most important steps in designing a study. " (Oxford Journal)

Further, it's kinda funny/comical in a way to me, IMO, to state "one" has been "randomized" when all there is, is ONE? That doesn't make a whole lot of sense mathematically, IMO? Typically, it would take a group, a mathematical "set", a "population" of something from which to "draw from" to create "randomization" - as it means dividing many, "randomly" and placing them into at least two, separate groups (thus, with one, one can only be placed in one group- so what has "it" been "randomized" against?), via using randomization. Not sure how a "set" size containing "one" is "randomized"? Makes no sense to me, mathematically or otherwise, IMO?

Take a jar full of marbles- and it's going to be "randomized"- one picks a person, blindfolds them, then they reach in and select a marble each time, and at every "selection" it goes in one of two jars- first jar "A", next "draw" goes in jar "B", back and forth until the original jar of marbles is empty. The two, "randomly picked" jars of marbles are now separated and taken to two different places. If the original jar of marbles contains one marble, and the "random picker" reaches in and picks the one and only marble, and places it into one of two new jars- it's simply been transferred to the other jar, it's not yet been "randomized" from an original set or sample population- as there was no original "set", there was only one.

Again, there are very specific probability rule/tools used to determine the sample/population size needed typically, to get true "randomization" and also guarantee then, that the outcome will have a definable rate of error and so forth. A sample size of "one" is not "randomized" in any practice/method I'm aware of?

That's how I read it, and it was released in July of last yr, and has never been heard about again, other than one, vague, "boiler plate" statement in the last 10-K, that I'm aware of. No further mention of more "enrollments" other than "one" at what " one center" or anything else has ever been said, that anyone knows of that I'm aware of? Let alone, any addressing the vague wording, describing something of the FDA having something "on hold", but they "intend" to continue to "enroll" while the "FDA issues" are being "addressed" (paraphrasing) that PR.

That's my opinion. Couldn't be more vaguely written IMO. At best, I'd call it "poorly" written by technical or engineering or medical style writing- which should be clear, definitive and bounded. Not "open ended", IMO.

That's it. My 2 cents. Make of it whatever one wants. I think it's vague, and for all one knows at this point, especially given the "no mention" in the last 10-K, MIRROR could be going "nowhere" for all one knows- everything else is just speculation IMO.