"I recall reading in the published Marvel results that patients in the placebo group experienced arrhythmia as well."? Huh?
So, AGAIN, BHRT just put that pesky ole "boiler plate" (I suppose, it's what many "claim" it to be supposedly) ole "so called" language in their own SEC filed, and Sr Mgt signed documents, and used "little" words like "Our product candidates may NEVER BE COMMERCIALIZED BECAUSE" and "INCREASED MORTALITY" and "SERIOUS ADVERSE EVENT(s)" and "SIX PATIENT DEATH" and "COMPETITOR CANCELLED TRIAL IN PROGRESS for SAME REASON", blah, blah, blah. (10-K, PAGE 31)
Sure. Yep. Makes sense IMHO. Yeah. Companies always like to put wording in their 10-Q/10-K when, when you know, it's just not really needed and doesn't mean a thing. Sure? Makes perfect sense IMO? Right on? Just toss some extra words in to what, make the 10-K read a little longer, more interesting? And leave it in every 10-Q and 10-K since, since you know, according to some, it never really means anything or serves no purpose anyway? Sure. Right on.
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."
