Provenge Nod Lifts Spirits And Stocks, But Also Sets High Bar For Success
Approval of Dendreon's Provenge is a major achievement and a shot in the arm for the growing field of therapeutic cancer vaccines, but it also serves as a reminder of the high bar for clinical and regulatory success in uncharted territory
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With the potential for a multi-billion-dollar blockbuster on its hands, Eli Lilly could conduct a confirmatory trial or even seek near-term approval of sola after pooled data revealed a hint of disease modifying potential in mildly affected Alzheimer’s patients, though the company also may be grasping at straws.
The cancer immunotherapy developer withdrew its IPO registration last month, turning instead to insider investors as it prepares for a pivotal Phase III trial on a dendritic cell treatment.