AGN: The not so good outcome is that a broader product label could be delayed to next year if it's a Class II.
All told, this is a good tradeoff for AGN, IMO. The broadened label for general upper-limb spasticity (not just spasticity attributable to stroke) outweighs the additional delay until final approval, which was probably inevitable anyhow due to the REMS. Moreover, off-label use of Botox in spasticity will probably increase to some degree between now and final approval.