AI
Saturday, February 20, 2016 8:24:47 AM
Beyond that if they would really have a problem with DCVax-L in any respect, due to Optune, then they should fire everyone, burn all the regulations, and start out with some finite number of central principals that cannot be violated.
Or, alternatively, they could elevate OS to an endpoint with alpha reserved and shoot for Full approval.
The FDA would treat is as a co-primary endpoint.
And, because of the x-over built into the trial, if they did this they would be comparing early vs late DCvax administration.
Who told us that this is what they were comparing?
The trials PI.
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