The FDA may refuse to file an application if, among other things, the application is “incomplete because it does not on its face contain information required under section 505(b) . . . and § 314.50 . . .” 21 C.F.R. § 314.101(d)(3). Likewise, the FDA will permit a rolling submission of an application for a fast track product only if it determines “after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective . . .” 21 U.S.C. § 506(c)(1).

In February 2017, the FDA accepted the NDA for filing after confirming that it was sufficiently complete to permit substantial review. Compl. ¶ 46; see 21 C.F.R. § 314.101(a). Not only did the agency accept the NDA for filing at that time, but it also set a brisk schedule for it under PDUFA, including a meeting of the joint advisory committee to consider the application.

18. Pursuant to 21 CFR § 314.101(d)(3), the FDA may refuse to file an NDA when the “application or abbreviated application is incomplete because it does not on its face contain information required under section 505(b), section 505(j), or section 507 of the act and 314.50 or 314.

See, e.g., FDA 0244 (“The receipt of an ANDA means that FDA made a threshold determination that the ANDA is sufficiently complete to permit a substantive review.”) citing 21 CFR 314.101(b)(1). If the Agency refuses to receive the application, it is not even reviewed by the Agency, much less approved.