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Monday, March 03, 2014 11:16:16 AM
AF previously predicted NWBO would fail (aka:"blow up")
AF currently predicts the NWBO trial will be continued and infers it will ultimately pass its primary endpoint.
(AF now has a fallback position that the Primary Endpoint should be OS not PFS.In other words, he argues more people should die around the world before this drug is approved.) Adam forgot to mention this is a treatment with orphan designation.
Here is a fairly comprehensive study on using PFS as a primary endpoint. Remember, NWBO worked with the FDA to develop their endpoints; moreover, if the first and secondary endpoints are statistically significant, there is no way in Hades that anyone would stop this drug from getting to patients if the extensions are nearly 6 months or more.
http://www.ncbi.nlm.nih.gov/pubmed/20167815
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