Extract to table

This memorandum analyzes the scope and implications of the deferral, outlines Penterra's ongoing obligations under the deferral and the Written Request, and identifies the actions that Penterra must continue to undertake even during any period of engagement dormancy or programmatic pause in the sNDA effort

Under the provisions of the FDA Reauthorization Act of 2012 ("FDARA"), Section 505B(a) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), FDA is required to specify in any deferral grant a date by which the deferred pediatric studies must be completed and the results submitted to the Agency

The study must be a randomized, double-blind, placebo-controlled trial with a 16-week treatment period

Penterra must submit annual progress reports on the status of the deferred pediatric study to FDA

Even if no study activities have commenced — which is expected to be the case for the first report, given that the adult program is still ongoing — the report must be submitted and should provide substantive information regarding the overall program trajectory

These annual reporting requirements are ongoing and must be met regardless of the status of the adult sNDA, the status of the CLARION-3 confirmatory trial, or the status of the engagement with outside counsel