Elite Pharmaceuticals Inc (ELTP)

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ELI-216 SPA 505(b)(2)NDA Commercial Approval Urgency

For ELI-216, Elite has a SPA agreement with the FDA on the pivotal Phase 3 study for which it has submitted a 505(b)(2)NDA approval request. Commercial approval for such cases would normally be within 12 to 16 months from start of the Phase III. However owing to the FDA extreme urgency to deter opioid abuse and multiple deaths the ELI-216 Commercial approval is expected to be given priority approval based on expected successful safety and efficacy results.

As for Pfizer engineering abilities, they have had considerable consolidation through multiple acquisitions resulting in heavy layoffs for cost reduction and essentially rely on the engineering staffs of the acquired pharmaceuticals such as King, Acura etc. When there are drug manufacturing problems within the acquired pharmaceuticals, it is their engineering staff responsibility to solve the problems and not Pfizer’s.