Regarding death/patient "adverse" events in trials:
Most recent 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."
That's their words (Bioheart, BHRT) and commentary from their, SEC filed 10-K, legal document- cut n pasted verbatim. Not my opinion or any words of mine.
Make of it what you will. They obviously, IMO had to insert it in the 10-K and other documents for "legal disclosure" requirements. It says what it says. One can form an opinion or make of it whatever they wish IMO.
Same 10-K, same page, 31 (just added info):
"In the SEISMIC Trial, we experienced delays attributable to slower than anticipated enrollment of patients. We may continue to experience difficulties in enrolling patients in our clinical trials, which could increase the costs or affect the timing or outcome of these trials and could prevent us from completing these trials.
Failures or perceived failures in our clinical trials would delay and may prevent our product development and regulatory approval process, make it difficult for us to establish collaborations, negatively affect our reputation and competitive position and otherwise have a material adverse effect on our business."
Again, their words, cut n pasted. Make of um what you will IMO. That area of the 10-K, pages 29 to about 31, IMO have some pretty important items in them. As in real important disclosures regarding the "trials", things already happened in past trials, and all the possible risks, adverse events, business implications, etc. Anyone doing due diligence, IMO should read the 10-K(s) always(all SEC documents IMO) cover to cover- but some areas/sections especially IMO, if they want the "true" picture as being stated in management's own commentary and words/wording.
Again, just my opinions and words from their own SEC documents- make of it whatever you want or form your own opinions.
