AdCom Vote Predictions

[silentbob]

While there is no way to predict a person's vote reliably without even knowing him, just for fun I'll share my own predictions:

For Type1: 7 in favor 3 against
For Type2: unanimous approval

On post-marketing trials; probably siding with the FDA (meaning: the expensive kind of trials).
On COPD, asthma, ... : probably excluded on the label.
On Fev1 testing ... possibly a recommendation of testing on the label after being on Afrezza X amount of time.
Ultra rapid acting... on the label
Hypo benefit... probably mentioned on the label but not without qualifiers.
Weight benefit vs injected, will probably only get a minor mention on the label.


I haven't sold any shares, and I haven't hedged my position, for whatever that is worth.
The biggest remaining risk seems to lie with the FDA's negative slant.
If that is a sign of outside influence then god help us all. If it is just a sign of caution, that is OK.

Good luck to all longs tomorrow!

[alcc]

Well put, as usual. I agree overall, notably: "The biggest remaining risk seems to lie with the FDA's negative slant."

I am less concerned re the adcom vote than I am the FDA decision process. If the writers and reviewers of the briefing doc get much input/influence (can't see reason why their opinion would not be relied upon) I am not hopeful re Type 1.