" You are correct there was mortality in the study, but causality was not shown do to MyoCell. "?? Really- that was proven beyond doubt? Where has that ever been stated in any company documents?
And "All-in-all, safety was not a concern"?? Again, really? That's not what the 10-K says?
From the COMPANY'S OWN WORDS, in their legally filed, most recent SEC document the 10-K, Dec 31st, 2013, 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."
That's the company's own words, in their SEC doc. It is not in agreement with the "claims" made in prior statement, IMO. Not even close, IMO. I know what I believe and trust. The company didn't put that verbiage in there because they wanted to, it looks bad, IMO. If they'd "proven" any of it, as not true or relevant or a strong risk- they'd remove it the sooner the better, IMO. They put it in there IMO, because they have to, under full disclosure laws, or the down-stream consequences could be very serious, and they know it, IMO.
