NBS received approval to continue the PreSERVE AMI P2 clinical trial following its 2nd interim data and safety review by the Data Safety Monitoring Board (DSMB).
The PreSERVE trial of AMR-001 is a P2, randomized, placebo controlled, double-blind study designed to treat 160 patients and is approved by the FDA to enroll up to 180 patients. AMR-001 is being evaluated for the prevention of major adverse cardiac events following acute myocardial infarction (AMI). Patient enrollment for the PreSERVE trial began in 1/12, and NeoStem anticipates completing enrollment in 2013 with initial data readout 6 to 8 months later <2nd ½ '14>.
The Bottom Line: The second external review of the P2 trial data confirms that there are no safety signals that would preclude the trial from continuing as planned. NBS has learned through principal investigators that the collection of stem cells and administration of AMR-001 is relatively straightforward for the treatment of patients within 11 days following an acute MI. The results of AMR-001 P1 trial and the large and growing body of scientific data and clinical experience, supports the continued development of AMR-001to succeed.
"BUY" - NBS had closed down at $0.53. Expectation is that NBS will regain its $0.60-$0.61 position - so, expect some more huge volumes <like the past 3 days where it had traded on 3/1.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.