Biotech Values

[jb_118]

re MNTA handicapping. How are you using the terms "undecided" and "rejected"?

How do you break out formal communication requesting additional information (generic version of an Approvable Letter) from the current situation where we seem to be in limbo? Is that rejected or undecided?

At this point I've assumed that the FDA is trying to figure out what their criteria/standards are for approval. Once they get that figured out it should be somewhat simpler to determine which applications meet the standard, since they've likely been through the applications backward and forward trying to work on a standard. I've kind of assumed a relatively contemporaneous response to all three companies.

If "undecided" is taken to mean the current state of limbo, I would think it relatively unlikely that one company would get a decision and the other wouldn't hear anything. Your probabilities suggest >50% change that if MNTA gets a decision, TEVA remains in limbo. I might be thinking of "undecided" differently than you are using it. Could you elaborate on your thinking?