Saturday, September 22, 2018 11:53:31 AM
"What I heard talk about was the importance of getting it right prior to or in the P2. So they have the final process prior to starting the P3, because once the P3 is underway the process is "locked down" as that will be the process licensed for marketing." -- ex
Ex, that would explain the 38 apparently having poor overall survival at 36 months. The trial changed to Phase III in MAY 2012. That is approximately after 38 patients enrolled. (See enrollment curve below.) If I was high tech like AVII or Senti, I'd measure and photoshop an arrow to where it looks like 38 enrollment occurred.
Improvement (projected) at 36 months at the end of the trial could be simply due to the final 31 patients being only randomized to the DCVax-L arm, however, some possible improvement (projected) before that might be due to, as Doc and I have been pointing out, safety improvements that partially enclosed the system (TFF), thus appeasing likely German patent demands. Thus your statement above might be tempered by safety improvements. Besides, who leaves a 17 year old patent to rot on the vine? We discussed this all long ago in that manufacturing changes do occur during phase III trials, but they require validation. If you ask me, Dr. Prins was publishing some trials that looked like they might also be used for validation/equivalency purposes.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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