He doesn't know if they will get BTD granted and the market doesn't know either. BTD is not just given out like tootsie rolls at a parade.


This is a link to a page where you can view the PDFs of the FDA stats for btds granted. Based on previous years and this year's about half get it and half don't.

So definitely not a gimme.
(See links under Approvals header for acceptance/denials rates)
https://www.fda.gov/drugs/nda-and-bla-approva...-approvals