Biotech Values

[Biowatch]

Re: DNDN #msg-18770820

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There are still a lot of questions, but my impression was that the advisory panel voted favorably because they didn't want to choke off the immunotherapy approach. The small sample size and post hoc analysis was of concern to the advisory panel, and to several members of the audience. It will be interesting to see what the FDA decides.

I strongly feel that the 9902b results will be considered, but the FDA may allow limited marketing before those results are ready. This would be a form of post-marketing follow-up, which is a weak point for the FDA.<

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Several members of th panel said that they did not want to stifle progress in a new approach in the field by voting no, even if it wasn't the most robust data package.

Several members in the audience were surprised at the yes vote, given the post hoc analysis ("cherry picking" the data), the small sample size, and the failure to meet the desired endpoints.<