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Wednesday, June 15, 2016 2:07:49 PM
That assumption of no enrollment after initial screening has already been debunked so good question. What I believe flipper44 might have alluded to is the possible petition for the addition of the pseudos into the trial results assuming an internal blinded review for the main arm was showing a strong trend toward outstanding efficacy. I am no expert on the review process going on but is it possible that if this is the case then either this would result in some sort of review towards approval, a denial of the request and eventual continuation of the trial to finish enrollment or a complete response letter depending on how regulators respond to the request and or data provided?
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