.0099 day's low. Two zeroes after the decimal.
So it already broke back below 1 CENT again even after the big "presentations" and all. I don't see any support at .0087 or wherever- I don't know where the bottom is on this one now. It seems like the bid can drop at will- like 20% or more in a blink and the volumes are still very high to the downside- this is not light selling. It looks like "big boys" selling for someone IMO.
So it seems like the PR and all the rest- just doesn't mean mo-mo buying or big "run-ups" like they used to perhaps? Some "PR fatigue" maybe and just too much pure, raw, massive common share dilution down pressure to overcome perhaps?
It's sure been looking awfully weak all into 2015 so far- despite all the PR good news and presentations and conference call and all? Maybe people aren't understanding whatever this new business model thingy is really all about or something? It's kinda confusing to me, that's for sure. I don't even understand what exactly they're selling or who they're "treating" for fees and all- when their own SEC filings say they carry no product liability insurance and actually that they have no "approved products"? That all still has me pretty confused personally- I don't really get it. A lot of the PR and "presentation" stuff seems to directly contradict their own SEC filing statements to me. And then Myocell not being under patent anymore and SDF-1 seeming to be licensed to some other firm now- Juventas or whatever they're called? And then MIRROR the big "phase 3" trial- after all that PR about 1.5 yrs ago and "fully funded by Bioheart"- now MIRROR just vanishes and is "cancelled" in this Jan 2015 PR, and apparently just never really even happened and was never really even "funded" at all, etc? Very confusing to me.
Like this statement from their own 10-K filings- I just can't seem to figure out then what they're now "selling" as "treatments" then for "revenue"? How can that be matched to this wording in the 10-K? It's very confusing to me?
Last filed 10-K, PAGE 39:
"We do not currently have product liability insurance because none of our product candidates has yet been approved for commercialization. While we plan to seek product liability insurance coverage if any of our product candidates are sold commercially, we cannot assure you that we will be able to obtain product liability insurance on commercially acceptable terms, if at all, or that we will be able to maintain such insurance at a reasonable cost or in sufficient amounts to protect against potential losses.
Claims may be made by consumers, healthcare providers, third party strategic collaborators or others selling our products if one of our products or product candidates causes, or appears to have caused, an injury. We may be subject to claims against us even if an alleged injury is due to the actions of others. For example, we rely on the expertise of physicians, nurses and other associated medical personnel to perform the medical procedures and processes related to our product candidates. If these medical personnel are not properly trained or are negligent in using our product candidates, the therapeutic effect of our product candidates may be diminished or the patient may suffer injury, which may subject us to liability. In addition, an injury resulting from the activities of our suppliers may serve as a basis for a claim against us.
We do not intend to promote, or to in any way support or encourage the promotion of, our product candidates for off-label or otherwise unapproved uses. However, if our product candidates are approved by the FDA or similar foreign regulatory authorities, we cannot prevent a physician from using them for any off-label applications. If injury to a patient results from such an inappropriate use, we may become involved in a product liability suit, which will likely be expensive to defend.
These liabilities could prevent or interfere with our clinical efforts, product development efforts and any subsequent product commercialization efforts, all of which could have a material adverse effect on our business."
Or this statement on PAGE 31 of same 10-K filing, in which they say pretty clearly- they don't have "enough data yet" on their "product candidates" to know if they're safe for use in humans- so what exactly are these treatment/therapies they're selling now in their so called "stem cell clinic" business segment on Slide #8 of that 8-K SEC filing "presentation" for what appears to be use on people/humans in South Africa or Honduras or Mexico and now I guess even on U.S. soil or wherever? I just don't get that either? Are they offering un-proven "treatments" to people/humans that are not part of a clinical trial in a FDA type trial based, controlled and monitored setting? Cause that's pretty much what it sounds like to me, just the way I'm hearing and reading what they're now claiming, seeing that Slide #8 of that 8-K presentation exhibit filed with the SEC?? Very confusing to me?
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 the PR and "presentation" stuff seems to sound like they're "selling" (as in commercialized) "therapies/treatments" like Adipocell? That's the way I sorta read/heard it explained? I could be wrong? But if one read that same 10-K filing, Adipocell is a "product candidate" and thus it says right there- that it's not been tested or proven safe for sure yet in humans?
Same 10-K, PAGE 53 (Adipocell is called a "product candidate", not a commercial product yet)??
"Biotechnology Product Candidates
We are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. In our pipeline, we have multiple product candidates for the treatment of heart damage, including MyoCell, Myocell SDF-1 and AdipoCell."
So what exactly are these "treatments" or "products" they're now selling in these "stem cell clinics"? I just don't quite understand how that works given that 10-K, very clearly written (IMO) statement above?? Just don't quite have that figured out yet?
