Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Portola’s Bevyxxa fails primary endpoint but is approved! Just fascinating folks pure and simple. In a P3 trial it failed its primary endpoint which should make secondary endpoints exploratory only and yet the FDA approved it. The FDA ran counter to its own guidelines. What a difference a year makes with the FDA. As you may know some of us longs such as yours truly were arguing last year that apaziquone should be approved even though it didn’t hit its primary endpoint based on the reanalysis of the data and knowledge that blood in the bladder could deactivate it. After the rejection, I felt a little silly that I argued for approval but at least now I feel I was somewhat justified in arguing for approval. This breaking precedent by the FDA is truly amazing.