Entdoc, I don’t think this CSM data mixup can do anything to deny the overall extremely positive results of Bavi in this randomized 2nd-Line NSCLC trial. No way you could have a group of relapsed 90%/Stage4 NSCLC pts that large living 12+mos because of Docetaxel-Alone, when historical MOS for Doce-alone is 6-7 months ( http://tinyurl.com/cgnkvpa ). I’m hoping that the mixup was only between 1mg & 3mg Bavi - in that case the “pooled” Bavi results, doubling MOS from ~5.6mos to ~12mos, will stand and I hope/trust will be favorably viewed by the FDA, as I’m sure they already are by our potential partners.
All we can do is wait and see how it plays out.
Oh, not that it wasn’t already important, but the 2H’12 MOS update in the Phase II Bavi+GEM vs. Front-Line Adv. PANCREATIC (randomized, unblinded) trial looms very large for our future. Of course, the longer we have to wait for Pancreatic MOS to be triggered the better, so sometime in ’13 would suit me fine.
BTW, CSM had nothing to do with the ongoing Pancreatic or 1st-Line NSCLC randomized trials, thankfully:
9-26-12: “According to the Tustin-based biopharmaceutical company’s complaint, Fargo, N.D.-based Clinical Supplies Management Inc. (CSM) ran one of 3 randomized, double-blind, placebo-controlled Phase II trials for the drug bavituximab as part of a testing services agreement with Peregrine. Bavituximab, a first-of-its-kind monoclonal antibody treatment that prompts the immune system…” http://www.law360.com/articles/381607
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