KT, just a comment related to your post excerpted in relevant part below:
The Phase III result was particularly difficult as Garnick et al were highly confident of an approval - most likely after the second look, and, as reiterated to me once again by a close associate of Dr. Garnick just last week, Bavi did indeed perform exactly as expected - actually better than Opdivo in a very similar trial - which really made our result that much more difficult to understand. Dr. Garnick did his job - Bavi should have been approved last year.