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Re: Investaholic33 post# 12311

Thursday, 12/18/2014 11:41:19 AM

Thursday, December 18, 2014 11:41:19 AM

Post# of 106833
"Setting up business in Nigeria"??

What exact "business" have they "set up"?? Where's the details, the money that was spent to "assume" this 49% ownership of this "vapor" location and some single, doctor's office practice at best or whatever this "entity" is they "assumed"? Kinda like the ole S. Africa "joint venture"? Like that one?

Overlay the S. Africa PR or the Honduras PR or any of um, and they're cut n paste templates except for changing the doctor's name and the population count of the "new" country. Does one really believe that the entire population of Nigeria, all 173 million, every man, woman and child and infant living there, the 173 million that they list in that "PR" (like they do in every carbon copy PR just like it) - that every person in Nigeria is now a "customer" or even remotely a potential candidate/customer for some "Stem cell" whatever via 4 person Bioheart and one "doctor's office" in ole Nigeria? Really?

Or, does one think the so called Nigerian "Ministry of Health" (if they even exist) is actually speaking with or cares one wit about "Bioheart" and stem cell whatever in Nigeria?

What exact "treatments" is Bioheart supposedly selling in Nigeria since their own SEC filings say they have 1) NO approved stem cell anything and 2) State in their own SEC filing they carry no product liability insurance for the very reason they have nothing proven safe or approved or salable yet and 3) State clearly their stem cell candidates have yet to be proven safe for use in humans???

So what exactly are they peddling down in ole Nigeria? What exactly?

From last filed BHRT 10-K PAGE 31:
"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."

But hey, I guess it's "good enough" for those folks down in ole Nigeria? Makes no sense to me? Selling un-proven and potentially very risky and unsafe "treatments" to be used on humans, per their own words in their own duly filed, legal SEC documents? What can possibly go wrong with that business model?

DOWN, SOLID RED making new 8 month lows on a day the market is literally on fire. Looks like the market place is just sucking up that "NIGERIA" joint venture, whatever ole news PR like a sponge?