$heff's $tation of $tocks & $olid DD

[$heff]

zmanl...this data of 320 evaluable (pt deaths) is second-line data in Small Cell Lung Cancer in pts who were already very sick and had relapsed on first-line therapy. This is what the FDA needed to see. These pts were going to die anyway the question was how long they could endure a second-line regiment.

""The 320th event in our pivotal registration SPEAR trial was defined in our SPA with the FDA to enable the Company to begin final analysis of data. Our goal is to complete and report the results of our preliminary analysis in the fourth quarter of 2009 and, if positive, initiate the rolling New Drug Application filing process for picoplatin by year-end under the Fast Track designation previously granted by the FDA," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "The SPA helps ensure that the design and clinical endpoints of our randomized trial and our planned analysis of the study are aligned with the FDA to support submission of an NDA."

What I am referring to for the forward-looking event is Phase II data presented on Sunday in 1st line Colorectal Cancer and not 2nd line small cell lung cancer for which that trial was deemed negative because the endpoint of overall survival was not met. CRC is a bigger tumor type than small cell.


Message in reply to:

Hello Sheff,

Are you able to shed more light on the following stmt that "on 9/15/09 PARD announced that 320 evaluable events (patient deaths) occured in its pivotal phase 111 trial"

Does this mean that 320 people died while on PARD trial drugs? If so how does did impact ongoing research of their pipeline

zman