Please go to 7:47 on the video when Dr Timothy Cloughesy is talking. Pay special attention to his comment on "not everything is going to happen within GBM Agile." I don't think it is a coincidence that Dr. Cloughesy is one of the leads in the program and the intent of this program is to take a look at ALL "drugs/agents" and evaluate them in an adaptive manner which will look very different from how the FDA has looked at clinical trial data. Keep in mind Dr. Woodcock went on to express that the FDA supported this new approach to clinical trials. I happen to think the FDA is taking a new stance and being very flexible in how they view GBM trials putting patients needs at the forefront given the dismal progress made in this arena.
How does this affect DCVax? Hopefully in a positive light. I think the long winded "partial clinical hold" has to do exactly with what I stated above and the required collaboration between different agencies and countries. All JMHO and certainly speculatory
Seems to me that moonshot and others are last ditch effort to get a ahead of DCVax-Direct. No mention of DC therapies even though they big pharma has shown DC potentiation of other therapies.
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