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Re: AVII77 post# 139369

Wednesday, 10/18/2017 10:49:37 AM

Wednesday, October 18, 2017 10:49:37 AM

Post# of 719335
"What OS results are needed to :
2. Be persuasive enough to allow approval (on a secondary endpoint after a failed primary)."

If I were an FDA reviewer i'd vote to approve it even if the HR came out with a p-value of 0.1 because of the harm-benefit trade-off:

1) It has minimal side effects
2) We're talking about terminal brain cancer here not hay fever
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