Tumor Regression. Could Direct speed past L?
I keep coming back to this in my head. I listened to the Oppenheimer replay again, and Linda's explanation for the reason it is taking a bit longer to see preliminary results in the direct patients.
Basically, initially, when conducting a phase 1/2 trial like this, they must move "slowly and conservatively" with the first few patients to make certain nothing bad happens.
After that, the enrollment can go at full speed and NWBO states they are literally "mobbed" by people who need therapy and want to enroll.
Think about that for a minute. The entire reason we have not seen the results yet is due to the fact that they are making sure nothing bad happens to the first few patients, but then enrollment will literally be completed immediately after they open the doors to the remaining patients.
Since tumor regression (and not OS or PFS) is the primary endpoint, the events should happen within 8 weeks of treatment. Once that happens, they will move into phase 2 for colorectal cancer. In phase 2, They will not have the initial "slow and conservative" bottleneck they had for phase 1. I think this puts complete enrollment for Direct/phase 2 out to June through July. The results are open, so we will know. If they have phase 3 ready (if the FDA needs a phase 3 at that point).
Think about that. The results from Phase 2 are also open and there will be no initial bottleneck like there was in phase 1.
NWBO can then start phase 3 immediately if the data allow. Will it go back to multiple cancer types in phase 3?
I think it would.
In that case, enrollment would once again be almost instantaneous. Tumor regression would be within weeks. The trial, if it follows the hopeful path, would be stopped early to give all patients treatment.
Could this all happen before the end of 2014? Yes, I think it could, but it all depends on the results from phase 1. If they are near an 80% response rate, than unless L is deemed a success by the board in its first interim, than I think it is feasible they will both be deemed a success at L's second interim. If L is not deemed a success by then, then I think Direct would beat L to the finish line.
