Replies to post #95928 on Biotech Values

[DewDiligence]

AIS explained the rational during their last CC…
1. Methotrexate is co-prescribed with alot of biologics given to treat RA at home.
2. IM injection is approved, but most individuals go to the docs office for their injection.
3. Once you start titrating higher levels of oral methotrexate 12-15 milligrams its not as effectively absorbed in gastro tract (sub-therapeutic level) & you start getting some adverse effects.

I don’t see how any of this makes a non-substitutable injectable more than a tiny-selling product.

[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?