(DNDN) - Dendreon - Hit many bumps in developing Provenge as a treatment for prostate cancer

Nadine Wong, discusses Provenge, which is Dendreon’s treatment for prostate cancer that is currently in development. The editor of the BioTech Stock Report newsletter updates investors on what is happening with the company’s BLA filing. Then this featured expert explains why share price spikes could be forthcoming. Commentary from September 5 Dendreon (DNDN) has hit many bumps in developing Provenge as a treatment for prostate cancer. However, management has reiterated the timeline for the completion of the BLA filing for Provenge in asymptomatic metastatic HRPC by the end of 2006, based on the data from the D9901A Phase III trial, along with supportive data from the second D9902A Phase III trial. And on August 24, 2006, Dendreon initiated the rolling submission of Provenge’s BLA. Nonetheless, Nadine Wong and her team wonder if the data conclusively supports approval, given that the first two Phase III trials failed their primary endpoints. Is the secondary median survival endpoint of time to progression of the disease and a side effect profile that was favorable, enough to satisfy the FDA? Wong and her team won’t know the answer until mid-2007 when the FDA reviews Provenge’s BLA. Over the course of the next 6-12 months, there will be opportune times to sell Dendreon during transient share price spikes potentially triggered by release of data from Provenge’s Phase III PROTECT trial, if positive; upcoming news flow from trials based on survival (expanded D9902B trial, for which enrollment has been accelerating, and supportive data from the D9902A trial); and the filing of the BLA. Dendreon has $105.6 million in cash at the end of the second quarter of 2006, which equates to about five quarters’ worth. Content Courtesy: Zacks Investment Research | Blog Home| VitalStocks Home