Hello Wilder,
I see you've answered your question....I think efficacy for POI is acceptable, see below, but they apparently used too low a dose for the OBD trials and that will have to be revisited or they had some other design problem with their trials.
Regarding the question about cardiovascular events, I think there must have been a non-significant trend towards more cardiovascular events in the alvimopan cohorts, compared with controls, based on the call. The FDA has apparently decided to use the entire 12 month safety cohort as a replication cohort for the other studies, to decide whether the trend is real or just a statistical fluke.
Based on the available information, the real issue here is that if the FDA acknowledges efficacy of Entereg in POI based on two positive phase 3 trials and two others that showed a strong, but non-significant trend, then they can't just ignore another trend in the data. In other words, ADLR can't have it both ways, and ask the FDA to interpret trends as significant for efficacy but not when the trend suggests toxicity.
I still think any increase in cardiovascular complications is very unlikely to be drug-related, but if the trend is replicated or if it is statistically significant, that would require some investigation and I doubt the FDA would approve the drug without further study.
I don't hold enough shares to make a killing, but my basis is now in single digits.
RE42 |
