Les advocates that all those who favour the FDA guidance write in comments in support. It will help to counterbalance and hopefully outweigh big P's opposition and strategies for delay.
One interesting comment that he did make was that if the guidelines are adopted, the cross-over issue won't matter. This will help NWBO.
Seems to me that although blinded, NWBO has a real concern with this and that there may be more than a possibility that this endpoint was not statistically significant and/or the endpoint was not achieved. I had mentioned to Les that regardless of whether there were significant separation or not, it was still a win situation. In the former, good for the trial. In the latter, suggestive that in cases of rGBM even without a second resection with updated antigens, there still is efficacy, but perhaps less than would be in the case of early vaccination. Late vaccination upon recurrence would still confer some efficacious benefit and perhaps even more so with a resection. Les's response was that there are constituencies who insist upon achievement of the trial parameters even though something new and perhaps unanticipated has occurred for the good of all patients--- requiring yet another trial. Hence, the guidelines, if adopted, would aid in NWBO's quest for approval by making cross-over a non-issue. This was my understanding.
I do hope that those on the board who support NWBO write in comments and spread the word. It would be especially helpful if MB members like Iwasdiver, Hopefulsurgonc and other physicians would encourage their networks to provide supportive comments. JMHO.
As someone who has been deeply affected by GBM and might have benefitted from a much more flexible and expeditious regulatory approach, I will write a supportive comment. I encourage others to do the same. GLTA.
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