Quarterly report on double blind study is this week!
The RESTORE-CLI clinical trial is a prospective, controlled, randomized, double-blind, multi-center study that is reviewed quarterly by a sponsor-appointed, independent Data and Safety Monitoring Board (DSMB). The DSMB is composed of third-party experts in vascular surgery, cardiovascular medicine, stem cell research and biostatistics. The DSMB has unblinded access to all available patient data. They review patient safety as well as efficacy information on an ongoing basis. At their September 24, 2008 meeting, the independent DSMB unanimously recommended continuation of the study.
``Treating the 30th patient in the RESTORE-CLI trial is a significant clinical accomplishment for Aastrom as we are now able to target the timing for the next milestone -- reporting interim data from this first set of critically ill patients,'' said George Dunbar, President and Chief Executive Officer of Aastrom. ``These patients face a high risk of major limb amputation and may benefit from Aastrom's VRC treatment.''
If they unanimously recommend the study to continue again ASTM may go above $1.00 and stay there!
I think the stock will pop even though this will be the sixth month for double blind study.The last time the board unanimously recommended to continue the study ASTM went up 35%.The study will be final and FDA approval in the next six months.I think another approval for the second double blind to continue is saying the FDA will approve the procedure.So next week is BIG!!!!!!! No later than Jan 2nd because of holidays!