One other thing to note is that the dosing trial that is ongoing may not get enough patients enrolled before Aug. PDUFA. The study was powered for superiority between Marqibo and standard viscrinstine. It could be true that the board was unimpressed with 15% responder rate in the study. However, talon tweaked dosing to max dose for efficacy while minimizing side effects to that of the original form of vincristine. Remember, this is an orphan drug for a patient population that once other anti-leukemia options are explored & have failed, are sent home to die. Would the board halt giving 15% of that patient population the chance to extend their life? I doubt it, when there is no other drug on the horizon for these patients. If standard viscrinstine could have done the job, wouldn't Eli Lilly keep the asset? Talon licensed Marqibo in 2006 after the FDA in 2005 turned down an application for the drug, filed by two other companies, to treat relapsed non-Hodgkin’s lymphoma.
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