Wall:
1. You were right the first time. If a Provenge dose for an ITT patient did not meet the minimum CD54 potency standards, and an additional leukapherisis was required, the trial enrollee and his doc would likely consider that the patient was in the ITT arm. DNDN could, of course, cover their tracks by asking for some extra leukapherisis from placebo patients, but that might be frowned upon ethically. My impression from Dr. Provost's transcript comments was that this is a rare occurrence and likely was not considered material in clinical practice.
2. When I inquired about 8015F given to placebo patients on crossover, I was told that the blood white cell product of each of their 3 leukapherisis was frozen, and then upon crossover, each was thawed and then processed individually as needed for each of the three crossover doses.
Good luck to you and all DNDN longs.
