InvestorsHub Logo
icon url

The_Q

08/15/20 9:10 PM

#32898 RE: GD #32896

Not just fosco but like everyone is saying north of 9% is 100% likely by January or earlier. Idk how you’re throwing anything else together. The last concern was a dropout issue and Geert cleared it saying the idmc would’ve mentioned it and they hadn’t
icon url

W_W

08/16/20 12:58 AM

#32901 RE: GD #32896

So for VICL, if the treatment arm OS was little bid worst than the placebo arm, then why they had 1.5+ years delay?
icon url

Fosco1

08/17/20 7:51 AM

#32926 RE: GD #32896

GD: regarding Vical's IDMC meetings recommendations, I do not know the specifics but

Usually IDMC meet at 50%, 75% of # of events, interim endpoints
This might be not enough to stop for futility, 25% being still far away from the full power of the study. It might be enough for efficacy if p<0.05 (meaning large effect size).
HR (which is a mean measure) might not be very meaningful, if the confindence interval includes the "1" value : was the Confidence Interval provided in the study you mentionned ?

In the case of Cel SCI , we are talking about a meeting held in April 2020, may be 1% away from final event. The october'19 meeting, likely 4% away from endpoint. This is very close from the trial design power, so I would say that if IDMC run a conditional power analysis, they have either seen futility or efficacy as a 99% outcome when trial finishes, or were still in the grey undecidable zone (around 10% benefit, but may-be with a 5% probability).