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wcopeland

08/21/17 5:13 PM

#1145 RE: Oren1976 #1140

Both of your points seem reasonable.

Remember also that attitudes of the FDA are shifting. Part of the shift can be explained by the Trump administrations view on reducing regulations and increasing competition. Another part can be explained by bipartisan legislation like the 21st Century Cures Act which has a soft spot for facilitating the development and commercialization of drugs for brutal diseases.

Remember also that the interim analysis was not going to tell us anything more than that the trial could proceed or not proceed. If DSMC looked at the same exact thing, it really could just be a simple matter of redundancy.

Remember also that a slew of immunotherapies have been disappointing recently (checkpoint compounds and CAR-T). With all of the hype surrounding immune oncology, perhaps the FDA is just trying to give a novel modality the best chance possible to make it to market in the hopes that once approved, it may be used in combination studies.

My take: there are so many reasons why the FDA allowed the interim to be skipped that it is likely impossible for us to deduce the true reason(s). Let's just be grateful and hope the expected science prevails?
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Jumpinjackas

08/22/17 9:52 PM

#1155 RE: Oren1976 #1140

So, was data unblinded?