IMUC believes that their live DC placebo had shown efficacy. My recollection is vague on this, which makes it questionable, but I think I read that IMUC has concluded that their use of a live Dendritic Cell placebo has tainted their results because these DC's, though not exposed to antigen, did have some efficacy... or did I hallucinate that?
I did a quick search for such a statement and did not find it. But some company, somewhere, that used live DC's for the placebo, and just didn't expose them to antigen, concluded that this was in fact occuring.
If so, a sweet and sour conclusion. If the efficacy for the control was large enough, then the extra steps of antigen exposure would be unnecessary... on the other hand, assuming there was still a significant increase in efficacy with antigen exposure, this would simply be an unfair test. In that case, the true test would be whether the FDA can properly arbitrate. The FDA would have the technical excuse of failing an additional 3.9 months PFS... but should they, if all indications are that the placebo was giving ie 3 months extra pfs (over what RK?... yes that is the problem, but if vs historical norms of the same era, for two different companies trials... then can you ignore that?).
Apparently for some subgroups this issue will be moot, although it would effect reimbursement levels, which are not quantized as go / no-go.
Does Northwest use living DC's as the placebo (unexposed to the tumor lysate) ? Can the FDA deal with this, or will they pull a Nurse Ratchet on NWBO? If they do, should we send Jack Nickolson or Matthew McConaughey to the White House to protest? (Maybe send McConaughey and friends to the White-House, but Jack Nickolson, solo, to the FDA!).
