FDA recommendationOdds greater than 50% the FDA has given its recommendation already.
If full go-ahead, I would imagine next PR is the formal filing. Surely the paperwork is complete and ready to submit.
If partial go-ahead and filing soon but not after some tweaking done, I would think a PR stating this. "BTD expected to be filed in November."
If another roadblock, will be silence.
I think it's 50 / 50 for options 1 and 2. Option 3 doesn't jive with IR's email blast.