Biotech Values

[Jonathan Robinson]

One very long NBIX holder has basically accused the FDA of reversing itself due to senior level personnel on the Lunesta approval decision, going so far as moving it from not approvable to approvable with a quick approval thereafter. There is some evidence in the file of something weird happening, although I must point out that the worry in that case (some cancer and pre-cancer evidence) came on a drug whose racemic form is the largest seller in Europe with no evidence of cancer increases. That would have provided an obvious angle to be less worried. AND I do find it hard to believe the FDA would have been lenient on a consumer focused non-life critical drug being used by millions in this environment.

Jon