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Re: CherryTree1 post# 384160

Friday, 06/11/2021 8:49:17 PM

Friday, June 11, 2021 8:49:17 PM

Post# of 686155
It's my belief that any advisory committee would support the approval of DCVax-L. In the case of the resignations, it was clear the advisory committee disagreed with the FDA decision. The FDA has been known to favor BP, and this seems to be a strong case for such action from them. Little to no benefit was seen in Alzheimer patients.

It's possible that the FDA has seen that the drug in combination with others may be more effective, and by approving it, they're allowing that to be tried. On the basis of first, do no harm, this may have been the right thing to do, but don't expect patients to be greatly improved with the availability of this drug.

The FDA has gone against their advisory committees on several occasions recently. In most cases they failed to approve a product recommended by the committee, clearly in this case it was the opposite, and I believe only one on the committee recommended its approval.

I'm still of the hope that NWBO partners with a BP before the FDA decision is due, I have little doubt that such a partnership will lower the likelihood of a delay in the approval. There is no doubt about the FDA's bias in favor of BP, in part because BP pays much of their bills.

Gary
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