"Our products are in the American process of getting FDA approved,"??
Really, which ones? According to their SEC filings, every FDA "trial" they have is ON HOLD for LACK OF FUNDING? They haven't advanced or made a dent in an actual "FDA TRIAL" in going on 5 yrs now?
From their last filed 10-Q, PAGE 29:
"We received approval from the FDA in July of 2009 to conduct a Phase I safety study on 15 patients of a combined therapy (Myocell with SDF-1), which we believe was the first approval of a study combining gene and cell therapies. We initially commenced work on this study, called the REGEN Trial, during the first quarter of 2010. We suspended activity on the trial in 2010 while seeking additional funding necessary to conduct the trial.
We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds."
Late 2009 and Q-1 of 2010? My calendar says we're now in Q-1 of 2015? There's no "FDA TRIALS BEING CONDUCTED" or pursued or whatever? When and where? Funded with what monies?
Mirror? The big "pr" event? ONE PATIENT "enrolled" and then never heard about again. The same old BHRT "story". That's gonna be "aging" to 2 yrs now too. ONE "enrolled" and all talked up in "PR" to try and boost the stock, then nothing. Never progressed another iota. Not happening per their own, duly filed, legally binding SEC statements.
Further, Myocell isn't even protracted under patent anymore- so why are they gonna pursue that?
Last filed 10-K, PAGE 40:
"We hold limited patent rights in our product candidates. Our MyoCath product candidate is protected by a patent, expiring in September 2017, in which we have an irrevocable co-exclusive license. Our MyoCell product candidate is no longer protected by patents, which means that competitors will be free to sell products that incorporate the same or similar technologies that are used in MyoCell without infringing our patent rights. As a result, MyoCell, if approved for use, may be vulnerable to competition in the form of products that use the same or similar technologies. We have previously licensed certain patents and patent applications relating to our MyoCell product candidate. These licenses have all lapsed as of the date of this report,"
AI
