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Message: Re: AGM agendas - Meetings Oct 31
5
Oct 10, 2019 09:54AM

"Note - we do not know the degree of BoM failure at this stage - hopefully p just slightly less than < 0.05% - I actually doubt that the p is just slightly less than 0.05 because they would have announced that aspect, would they not? They were very guarded in their language using the terms like scientifically rigorous."

That's the billion (or multi-billion) dollar question. Was it a near miss on the p-value or a total miss? At this point, it could have been an impressive >30% RRR with a near miss p=0.06, or a modest <10% RRR with a total miss p=0.6. Just an example. If just a near miss, then many of these pre-specified sub-group analyses could give extremely impressive %RRRs with significant p-values.

However, this won't change the fact that the primary endpoint failed to achieve statistical significance. Would the FDA approve apabetalone, in the face of a failed primary endpoint, based on stellar pre-specified sub-group analyses of the primary endpoint and/or for CKD/cognition sub-studies, as Jonzobot also asked? I wish I knew more on this topic. My guess is that this is a long shot. Hopefully, management sheds some light on this issue at the upcoming BIO Investor Forum and AGM later this month.

I've re-read the top-line news release several times and it is really hard to read too much into it. It leans positive, in my opinion, but they are holding their cards close. Tick tock.

BDAZ

7
Oct 10, 2019 02:05PM
8
Oct 10, 2019 07:32PM
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