Lannett Company Plunging

Lannett Company, Inc. LCI is plunging today, down more than 16% on no news. The company's PDUFA date is approximately December 26. Aa PDUFA is a Supplemental New Drug Applications (NDAs) or Biologic License Application (BLAs) are filed to obtain FDA marketing clearance for a new use, strength, or formulation of an already approved drug / biological agent. The FDA typically responds within two months to formally accept and issue a PDUFA goal action date for all NDAs while there is a 14-day period to formally accept and issue a PDUFA goal action date for resubmissions to Complete Response Letters (CRLs). The PDUFA goal action date is a performance metric that seeks to review all NDAs, BLAs, sNDAs, or sBLAs within 6 months for priority review and 10 months for standard review, 2 months for a Class 1 Resubmission, and 6 months for a Class 2 Resubmission.