Biotech Values

[drbio45]

ENCY/GILD - How does the FDA approve a drug with significant safety issues, but fails to approve another drug for the same indication for failure to demonstrate effectiveness when three regulatory agencies have not questioned the efficacy data? The agency even admits that the data indicates an improved exercise tolerance. Somethings wrong with this picture.

evidently there was something in Encysive's data as far as safety that the FDA didn't like. I have no idea what it was and Given claimed he wasn't going to tell for compeititive reasons. That made sense to me. The fact the Gilead was approved and doesn't seem to have the same issue leads me to believe it wasn't a class effect but something different about thelin in particular and he was lying.

Again I don't know what the problem is and I don't know if it will ever come out. I can't see European doctors prescribing Thelin without knowing what the issue is.