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Monday, February 22, 2016 11:59:37 AM
(Blame it on Mapman. The slightest encouragement, and some people just won't shut-up).
These issues very much old-hat I realize, but I need to review:
Someone please correct me if I am wrong about the following things:
1) LP says no 1st interim was done.
2) While LP may or may not be required to announce the 1st interim, she is certainly not allowed to lie about it. Therefore, I am comfortable with believing that the 1st interim had, in fact, not been reached back when she made the statement.
3) That allows that the current hold might be related to a look at data at the 1st interim. It might be simultaneously many other things, including a look for the benefit of Celldex, but it might very well be a planned look at the data at the 1st interim.
4) While it may seem inconcieveable that the 1st interim is only now being reached, we would be talking about the new and improved 1st interim, which would be a larger number of events than the original trial 1st interim. Maybe that makes it feasible. I know people have addressed it a hundred times.
5) LP may not be required to announce that they are at the 1st interim review. This is where I am feeling unsure. I know people here know. Or did she actually say that they are not currently in an interim review? I don't think so. I think she said that before this hold. I know you guys know.
6) Can you decide things like the early approval that we all dream about at a 1st interim review? The second interim is usually deemed the efficacy review. But I would think any reveal that is planned can be a period for such decisions, just that it would be unusual. But multiplicity category constraints might say no; that a look at efficacy for consideration of any kind of approval must not only be at a planned interim, but that it must be at a planned interim for efficacy. Sounds like the kind of debate that at least four of you are tired of hearing. But any input there?
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