Biotech Values

[DewDiligence]

GNVC: data from the next peak at 184 events should yield stat sig if the data holds this line of efficacy

I strongly doubt that. The alpha allocation at the interim analyses in cancer trials is ordinary tiny. If HR=0.75 is maintained at the second interim look, the p-value will be lower than it was at the first interim, but it probably won’t be low enough to meet the alpha allocation.

the CI is barely over the threshold of 1.00. actually 1.15.

You need to be careful with mixing apples and oranges. You’re referring to the 95% confidence interval at the first interim look; getting the upper bound of the 95% CI below 1.00 is sufficient only if the alpha allocation for the analysis in question is 0.05; however, as stated above, the alpha allocation for the second interim look will be much smaller than 0.05. In other words, a p-value of 0.05 at the second interim look will not be sufficient for a statsig outcome at the second interim.

My investment advice, FWIW is as stated in #msg-38314299: hold off on buying GNVC until after the second interim analysis fails to hit its p-value threshold and the trial thereby continues to a final analysis. Then, if the HR at the second interim is disclosed and it remains at about the level seen at the first interim analysis (0.75), the stock may become a worthwhile gamble.