On POTP news
Dew, you are right about no SPA.
Here's an excerpt from the Jan 2006 webcast --
<<Proposed Indication: In combination with chemotherapy for
metastatic NSCLC after failure of at least 1 prior
chemotherapy regimen
• Primary endpoint consistent with Oncology Drugs Advisory
Committee (ODAC) recommendations (December 2003) and
FDA Guidance (April 2005)
– PFS is a strong endpoint in blinded, placebo-controlled randomized
trials
– Independent radiological confirmation of progression
• Clear guidance on registration endpoint
– No SPA requested
Proposed registration trials
• Two randomized, placebo controlled, double-blind trials (ongoing)
– Talabostat/docetaxel vs. placebo/docetaxel (N=400)
– Talabostat/pemetrexed vs. placebo/pemetrexed (N=400)
• Independent imaging review
Primary endpoint
• Progression-free survival
– 80% power to detect a 1.4 hazard ratio between the two arms
• e.g., in docetaxel arm, based on prior studies, a PFS of 4.06 months vs. 2.90
historical is required
Secondary endpoints
• Survival, overall response rate, duration of response, quality of life>>
You are saying that if SPA is not involved, they don't need written agreement with FDA to conduct an unscheduled interim analysis.
What will it take for the clinical data related to the 150 events (mentioned in the PR) to be released to the company?
AI
