Manipulators, will only cover if they think they need to. One of the bear arguments is that the old strict standards will still be applied to this trial and that they believe this trial has failed to reach the originally specified endpoints which means no approval under any conditions. This is the argument that Dr. Linda Liau was trying to preemptively attack by suggesting that there should be a way for a trial like this Phase 3 to garner approval for patients where benefit is being found in the long tail. The treatment is designed to be safe and tailored to each individual patient each of whom will respond differently depending on many different correlations and not just a response to a single tumor associated target. If able to establish who is benefitting on a blinded basis, ie Direct patent claims about knowing who will respond based on the ability of their DCs to produce certain cytokines at prespecified levels, then Dr. Linda Liau is suggesting that regulators should approve for at least those patient groups that achieved this correlation. We believe this can and will happen. There are some staunch bears who I believe have bitten into that argument way too deeply while the most savvy know better. Interesting times ahead. Best wishes.
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