Subsequent Events

12 Months Ended

Dec. 31, 2021

Subsequent Events [Abstract]

Subsequent Events

Subsequent Events

As discussed on Note 1, Organization and Business, in February 2022, the Company received notice from the FDA of its acceptance for review of the NDA resubmission for SPN-830 (apomorphine infusion device).

In February 2022, the FDA approved the first generic of Apokyn (apomorphine hydrochloride injection) to treat hypomobility "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced PD. This approval is for an application of the drug cartridges only, which are compatible for use with the APOKYN pen, the brand-name pen injector. Patients treated with generic apomorphine hydrochloride will need to separately obtain the APOKYN pen. The Company is in the process of analyzing the impact of the FDA’s approval of a generic apomorphine hydrochloride injection drug cartridge to both the Company’s operations and the corresponding intangible asset.

The 2023 Notes include a covenant requiring the Company to provide Noteholders copies of all reports that the Company is required to file with the SEC pursuant to Section 13(a) or 15(d) of the Exchange Act within fifteen calendar days after the date that the Company is required to file or furnish such report (after giving effect to all applicable grace periods under the Exchange Act) (such date the “Outside Filing Date”). Although this Annual Report on Form 10-K was not filed with the SEC prior to the Outside Filing Date, it was so filed prior to the sixty-day cure period provided under the terms of the Notes.