Elite Pharmaceuticals Inc (ELTP)

[Gman24]

This is why Elite is selling some of the pipeline... to save $1.1 million dollars..


The FDA’s Generic Drug User Fee Amendment (“GDUFA”) fee structure includes fee brackets that are based on the number of ANDAs owned as of the April 1st annual measurement date. As of the measurement date in 2018, the Company qualified as a medium sized company, which is defined as an entity that owns between 6 and 19 ANDAs. During the fiscal year ending March 31, 2019, the Company received approval for several ANDAs, which, when added to those approved in prior periods resulted in the Company owning in excess of 19 ANDA’s and would have required classification as a large sized company as of the 2019 measurement date. Based on the latest fee schedule published by the FDA in August 2018, the annual fee for a large company is $1.1 million higher than the fee we paid as a qualified medium company. Qualifying as a large sized company would accordingly result in a significant increase in annual regulatory fees.