Perhaps MRK's strategy to run full clinical programs and submit BLAs for its FoBs reflects its view that the FDA will require such pathway anyhow.
I hate to belabor the semantics, but I don’t consider a drug submitted under a standard BLA to be a bona fide FoB; it’s simply a branded biologic.
I maintain that MRK’s top brass was deliberately clouding the issue on the Dec 9 webcast because they knew that FoB’s are “hot” and analysts and reporters would run with the story.
If MRK had merely said it plans to develop biologics, the story wouldn’t have had the same sex appeal.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”