Biotech Values

[DewDiligence]

ALTU – I just listened to the CC. This drug has zero chance of FDA approval absent new, convincing data, IMO.

>They hit the statistical significance BUT their SPA called for a 20 point increase in CFA for the below 40 subgroup which they didn't meet.<

It’s worse than that. The FDA wanted to see a thirty point placebo-adjusted benefit in the sub-40 subgroup, but only a 15-point benefit was observed.

ALTU’s assertion that only a 20-point benefit was needed to satisfy the FDA was spin derived from a disingenuous use of the 95% confidence interval.

Even if (for the sake of discussion) the FDA were willing to accept ALTU’s spin, the trial missed the 20-point threshold, forcing ALTU to try a hopeless plea about geographic subgroups.




“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”