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Dragon Lady

04/05/17 9:50 AM

#47518 RE: wallas2g1 #47509

Quote LOL, "ceos can't scrub SAE info"

WHAT????? WTH???

WHO WRITES and INKS THEIR NAME ON EVERY DAMN SEC FILED 10-K or 10-Q??

WHO??? Oh...the CEO, that's who.

TRY and find the info below in ANY SEC filing after the 2013/2014 period. IT WAS PURPOSELY SCRUBBED OUT. Potential shareholders, potential investors will NOT SEE IT, if its been SCRUBBED FROM THE CURRENT 10-K, where it belongs.


https://www.sec.gov/Archives/edgar/data/1388319/000114544314000356/d31044-10k.htm

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."

YEAH, I guess all that FACTUAL INFO just magically REMOVED ITSELF in all later SEC FILINGS? Right on, LOL !!