Biotech Values

[DewDiligence]

LLY/INCY have a lot of work ahead to get Baricitinib approved, according to the PR you posted:

The letter indicates that the FDA is unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms.

The companies disagree with the Agency’s conclusions. The timing of a resubmission will be based on further discussions with the FDA.