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Saturday, January 02, 2016 11:39:02 PM
In my view there is a need for such a view to always be expressed. At the same time, I think that it dangerous to rely only on such a view; but Flipper recognizes that, and so includes a disclaimer stating that at the bottom of his posts.
I have never seen an investment recommendation in Flipper's posts. At least I can't think of one. Not that such would be a crime. Just not his style.
If AA is on the table, Northwest might not mention it if they don't have to. The odds are that the implied efficacy review would end with a continue, and disappoint, and they can't afford that. Further, there is always some chance of it ending worse than a continue, something else they would probably not want to talk about.
I recently made an argument for why an efficacy review is very likely in progress. The board was pretty empty, but some thought the arguments made a lot of sense. The argument was basically that the numbers of screened and randomized patients matches the number that would be needed for a confirmatory trial after AA based on 4+ months PFS projected, and 6+ months PFS projected, respectively. Those being the new and old primary endpoints respectively.
In retrospect, I should not have focused on AA for that argument. The patient numbers needed to perform a confirmatory are the same numbers that would be needed to just continue the trial without AA. However, any efficacy review has some possibility of AA / early marketing approval with confirmatory, as well as some chance of halt for futility.
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