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colmar

01/14/17 5:17 PM

#95729 RE: kabunushi #95728

interesting, any idea what time may be involved in this route? Thanks.
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Doktornolittle

01/14/17 7:18 PM

#95739 RE: kabunushi #95728

Sounds good. So you think they may be waiting for a reply from the FDA regarding NWBO's final, final proposed subgroups scheme, or some other related issue.

I like that. I like it because I don't remember them talking about mesenchymal as a subgroup in the past, and I want to believe that subgroup shows great response.

Mesenchymal more immunogenic... why would that be? Less blockade function? If so, then clearly it would have to have other things going for it, as a cancer, that offset that weakness. But perhaps those other things are no match for DCVax-L... if it does lack blockade function.
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iwasadiver

01/15/17 8:45 AM

#95765 RE: kabunushi #95728

I believe you're correct in this assessment. My conversations with NWBO over the past year reflect a consistent message that "there are many ways with which we can win" with this technology. The "ongoing dialogue with regulators" I feel has been a constant lobbying if you will about allowing flexibility in resulting data analysis because of the fast pace of new evidence that is showing that traditional chemo/drug therapy statistical analysis for FDA approval are not effective in presenting the clinical effect of immuno therapy biologics.