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Astavakra

01/19/14 2:11 PM

#3451 RE: gpb #3450

A good example of how 'data' can be interpreted differently: I thought he was either going to have a highball in a go-go joint, or maybe, maybe, going skiing!

longusa

01/21/14 12:34 AM

#3470 RE: gpb #3450

gpb / flipper, thanks very much for the detailed discussion.

I wanted to check my understanding of what you are saying about the interim: I think you are both saying that - depending on what the actual enrollment timeline looks like up to approx April 1, 2013 (approx. 6 months before the announcement Dec 10 that 60% events had been hit) - there is a good chance that the primary endpoint of 6 mo PFS could be achieved with stat sig of p <.05, thus enabling the stopping of the trial early for efficacy. Did I capture that correctly?

Another question if you are game to come at it a different way: if PFS outcomes are as each of you assumes (with flipper using longer PFS's), what is the minimum number of patients that would have to have been enrolled by April 1 2013 to get the primary endpoint met at this interim with p <.05? This could give us another handle on likelihood of an interim stop for efficacy given we have a few data points on how many trial sites were open at various times from 2011 on as a proxy for enrollment levels.