Biotech Values

[DewDiligence]

>Why issue a not approvable if it is simply a volume thing?<

Agree—the non-approvable letter for the “modified release” tablet is clearly not just a workload issue.

The reason the stock is down so much is that the MR tablet is the only Indiplon formulation that had a chance to get a sleep maintenance claim. Even in the best case, the immediate-release capsules will only be able to get a sleep induction claim, which won’t stand up to the competition in the marketplace.