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davidal66

05/18/16 10:27 PM

#293 RE: gr8db8 #292

Yes. Also interestingly the CBS 60 minutes story on the modified polio virus against rGBM is another example of selective inclusion criteria.

The polio virus median overall survival data in the Duke trial is about 15 months. Sounds great, and it is intriguing, but the inclusion criteria for the Duke trial is stringent in terms of a. tumor size b. tumor location, i.e. the tumor cannot be near the ventricles, c the tumor must be a certain distance to the skull(I'm not sure about brainstem tumor, but don't think they are included). To be fair, much of the inclusion criteria was mandated by the FDA who are being cautious up until now because of the unknown toxicity with polio, but these restrictions on inclusion to a phase 1 or 11 trial could skew survival data.