Another "vague" PR IMO. Should have checked my calendar, guess it was time for a "PR about something", though.
"Bioheart, Inc. Announces Update on Phase I Adipose Stem Cell Trial": SUNRISE, FL--(Marketwired - May 5, 2014) - Bioheart, Inc. (OTCQB: BHRT)
Gotta read this one carefully, as always, IMO- what does it really say?
Here are the extremely "vague" parts (typical) IMO:
"The patients were recently contacted to assess quality of life. The patients have reported that they are in good spirits and doing well. According to the American Heart Association, about half of the people who develop heart failure die within 5 years of diagnosis. The most compelling data from this trial is the strong safety profile. All adverse events were adjudicated by an independent data safety monitoring board and deemed not related to the therapy. In addition, the four year information from the original pilot study demonstrates preliminary long term safety of the AdipoCell product.
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1) The "patients" were "contacted"? How? By phone, via a written questionnaire? How and by whom? Did the Mexico clinic do this "survey" to "assess" or did "BHRT"? There is no way IMO, to discern any of that, the way this is written. Further, was some sort of "generally accepted academia or industry" style questionnaire format followed? They of course exist for this type of medical, clinical research follow up- most have specific names, are peer reviewed, standardized for research, etc. They would typically be reported IMO, using some sort of graded, scale rating- as in qty-50, written "quality of life", very specific questions, graded on a 1 to 10 scale for example, would be filled out on a standardized written "assessment" survey.
I've never , ever heard or seen it reported that a medical follow up, as in a formal, clinical research type follow up was done, and the answer was , "The patients have reported that they are in good spirits and doing well." ?? Huh? What? That is scientifically meaningless and useless information IMO. How can anyone possibly measure that or compare it against some baseline. As opposed to some standardized, 50 question academia/research style follow up, formal written questionnaire- in which the summary would say something like, "All 5 patients scored 70% or higher, on the Jones-Smith quality of life index study scale, and 85% or better in the 25 question Johnson-Robertson, functional, quality of life XYZ standardized survey rating." Something to that effect. This sounds like someone could have called each person up, simply said, "Hey Bob, how ya feeling- do you feel good, like your life is OK?". Bob answers, "Yeah, everything seems pretty cool and all- I felt pretty good this past week. Walked my dog twice." Thanks Bob- end of follow up "survey". Classic "vague" IMO. I don't know how anyone could/can possibly follow up on this as reported, ever verify it, quantify it, etc. Let alone prove that the claim being made, that it someone demonstrates "safety" or something?
Does one really think the FDA or similar would believe this "follow up" as reported- is enough to "demonstrate safety"? I've seen FDA "safety determination studies" and they are notebook thick, with 100's, if not sometimes a 1000 pages or more- of statistical data, lots of numbers, graphs, charts, sophisticated mathematics, formal verbiage using standardized academia, or peer published research studies, standardized-sophisticated follow-up questionnaires and "adverse event" tracking/reporting methods, in "generally accepted formats", etc. This IMO, this "follow up" is vague. It's worded IMO, like someone doing a questionnaire on whether or not people like a particular brand of soda or something. It sounds like a poll or something IMO- more than a formal academia, research style "follow up" results IMO. I mean really, "They all reported being in good spirits"? What does that even mean? Happy? Cheerful? Who measures "being in good spirits" and on what scale- some kind of depression/happiness scale or what? They reported they were "doing well"? Again, in medical or science terms, what does that even mean? Hey Bob, "How ya doing, you doing "well"?" Bob, "Yeah, not bad". Thanks Bob- scientific "study" is completed? Makes zero sense IMO, and in no way that I can see - is verifiable, quantifiable or repeatable as written, IMO.
2) " All adverse events were adjudicated by an independent data safety monitoring board and deemed not related to the therapy."
Classically "vague", again IMO. What "independent data safety monitoring board "? Who? What's their name? Where are they located? Is this info published anywhere? Peer reviewed, etc? Every "board" I know of has a NAME- PRINT IT and STATE IT? What's the mystery about? And, apparently there were "adverse events" as they needed to be "adjudicated" - so WHAT WERE THEY? And by who's "standards" were they "adjudicated? Per standards of the FDA or some other, similar, well respected regulatory body? Was any of this published and peer reviewed to deem it "safely adjudicated", etc? VAGUE as can be IMO. It doesn't even list a name for the supposed "independent body"- whoever and wherever they are and what their title and credentials are? WHY? Why would someone, reporting on a medical research type of sophisticated study and "independent review group" (supposedly) IMO, not list the specific name and contact info for this "review board" or whatever or whoever they are? Again, the way this is written, IMO, it is 100% impossible to verify it, confirm it, etc.
Just another "PR about something" IMO. Vague as can be- and not, IMO, written in any, generally accepted type of medical research style or format. I don't think any credible medical journal or similar- would ever print or accept data/info in a format like this, such as "review boards" without even their name, location. etc being given.
That's my 2 cent opinion on it. And that's not even getting into the apparent reality- that when compared to the recently presented 6 month follow up data, done on 5 patients at the same facility, for what is being deemed the ANGEL, phase I "trial"- that the data/performance/outcome on this more recent trial, 6 month data appears to be worse, than this 4 yr old "study" (100 meters then, versus 68 now and 13% then versus 10% now on the ejection measurement?).
Buy, sell, hold, do one's own due diligence or whatever- but that's my opinion on the "PR" from today. Makes zero sense to me, and is "vague", which IMO, is a typical BHRT "PR" release. It leaves out a huge amount of details and info IMO, info that would be very easy to include and state in the PR, and IMO, would be customary to state in such a PR, so as to make it verifiable and easily tracked by other researchers, independent press/journalists, medical writers, or anyone else wanting to follow up on it, verify it, etc.
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