We’re now conducting the independent endpoint assessment and adjudication process for the primary efficacy endpoint response rate. The process is two steps, radiology and oncology, and they’re conducted in that sequence. We reviewed this process in detail in our last call, so I won’t go through that process again today. But I’ll remind you that both the committee, which is doing the adjudication, and the company, remained blinded throughout this process as to whether each subject was at the treatment arm or the control arm.
This entire adjudication process is expected to take several months. It’s a rigorous process and the results will remain blinded until we each trigger – until we reach trigger for the secondary endpoint of survival. For the survival endpoint, we are tracking the overall number of death events with the trial. We are blinded to the number of events for study arm. And just as a reminder, we are tracking the survival in a separate database.
Our Phase 3 trial was 90% powered to detect the survival difference of 18 versus 11 months. Now, if these survival assumptions were accurate, we should have reached the target number of death events by now. Since we have not, we know that the control arm, the treatment arm or both may be living longer. To value these alternatives, we looked at some additional information. As a proxy for Phase 3 control arm, we looked at 61% of the patients in our high dose Allovectin Phase 2 trial who received one cycle or less of treatment which should have provided minimal survival benefit.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV