"Once approval occurs"?? Oh, FDA "approval" is just a few tiny steps, maybe a few pieces of paper, a few dollars away? HUH?
Baxter has a registered, phase III trial of heart-stem-cell treatment, it's posted right now on clinicaltrials.gov. The phase III began in 2012. It is not expected to even have "final data" until 2016. Two more yrs away for a total of 4 yrs for the trial. And that is not even "submitting" to the FDA, let alone how long a review can take- easily 10 months a yr or more, let alone do they ever approve it? http://clinicaltrials.gov/ct2/show/NCT01508910?term=baxter+stem&rank=9
Enrollment: 291 Study Start Date: April 2012 Estimated Study Completion Date: June 2016 Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
What does BHRT have that is even remotely close to FDA "approval occurring", when they are functioning on cash that lasts a month or two each time and spent a total of about $600K R%D last yr (per the last 10-K) - which would be the "trial" funding money from what the 10-K indicates, IMO? $600K is noise level money IMO when it comes to conducting a phase II or III trial? Companies routinely spend $10's of million at the phase III level, often in the $100 million or more range.
Just tossing it out there that "when approved" or as soon as "it's approved" doesn't mean anything is going to "Get approved" by a long shot, IMHO. There has to be reality and some cold, hard facts to back up major claims like that. MIRROR barely got a passing mention in recent SEC docs and the big blog update? Why?
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