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In this section: Prescription Drug User Fee Amendments

Exhibit 2-2 long description

The major difference between the CMA Pilot 2 program and the Fast-Track program is the number of scheduled FDA/sponsor interactions. The Fast-Track program starts at the end-of-phase 1 (EOP1) meeting and generally has two other formal meetings scheduled, the EOP2 and the Pre-NDA/BLA meeting, with possible other informal meetings scheduled at random times. With CMA Pilot 2, in addition to the landmark meetings mentioned for the Fast-Track program, there are other planned meetings including a Preclinical-ADME plan, CMC-stability, CMC-validation plan, Clinical-Phase1/Phase 2 results, Clinical-Preliminary Phase 3 analysis, CMC-Phase 3 results and CMC-PAI plan. Also there is guaranteed FDA feedback within an agreed to time frame in the CMA Pilot 2 program.

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