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Re: IkeEsq post# 209698

Wednesday, 01/23/2019 9:12:51 PM

Wednesday, January 23, 2019 9:12:51 PM

Post# of 690919
An interim analysis for efficacy is where someone who is designated to do so (like the Data Monitoring Committee or some such group) officially looks at the efficacy data in an unblinded manner. It uses some alpha to so do. There was to be an efficacy look at PFS when they reached a certain percent of - I think it was 80% or so - the PFS events.

According to the protocol, they were only to be done with the PFS data set.

Some bears have claimed that an efficacy look was done and that the trial was found to be futile.

Of course, if they'd done one, and futility was the finding (not a possible futility - I mean futility) many would argue that such a finding should have been made public.

Now... I don't personally think a formal one was done. I think there may have been a strong suspicion that there may have been an issue with PFS - one that may have forced the FDA to look at it - but I am speculating here. I don't think the company ever did. Still... I can understand why flipper would like to have that clearly answered.
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