Wednesday, December 05, 2018 12:18:13 PM
I could see a small mathematical crossover adjustment being allowed if certain parameters are met....not sure they will be needed or will be there.
If some extended life after progression and exposure (on average) to DCVax-L for first time after progression. (not certain this will require much adjustment, because only three patients received DCVax-L after second surgery. I have to believe second surgery is key for crossover to have a chance to get much traction for naive cross-overs).
On the other hand, if manufacturing improvements made in DCVax-L when converted from phase II to phase III (or perhaps any possible fine tuning thereafter), makes second surgery less critical for (potentially optimized) DCVax-L therapy after progression to work in DCvax-L naive progressors, than a larger mathematical adjustment may be necessary. Again, it would be the DCVax-L naive patients that crossover looking at their time from progression to time of death (in comparison to other arm and historical). Pretty straightforward.
If some extended life after progression and exposure (on average) to DCVax-L for first time after progression. (not certain this will require much adjustment, because only three patients received DCVax-L after second surgery. I have to believe second surgery is key for crossover to have a chance to get much traction for naive cross-overs).
On the other hand, if manufacturing improvements made in DCVax-L when converted from phase II to phase III (or perhaps any possible fine tuning thereafter), makes second surgery less critical for (potentially optimized) DCVax-L therapy after progression to work in DCvax-L naive progressors, than a larger mathematical adjustment may be necessary. Again, it would be the DCVax-L naive patients that crossover looking at their time from progression to time of death (in comparison to other arm and historical). Pretty straightforward.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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