Biotech Values

[acgood]

I did not hear the webcast yet but that is a definite delay in the NDA filing to expand the safety study. That was always going to be the rate limiting step for the libigel program, especially after they halted enrollment for a time when cash was short.

If I had to speculate, it seems as though the lower than expected rate of CV events across both arms is coming back to bite them- ie, they are needing more patients to demonstrate their threshold of non-inferiority. The trial is measured by a composite of 6 CV events, but it NOT driven by a pre-specified number of events. If I recall they are allowed to have up to 30% higher events than placebo or something like that. Did they give a reason during the presentation?