ATH 25.0% 0.5¢ alterity therapeutics limited

This is taken from an End of Phase 2 Meeting Presentation by...

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    This is taken from an End of Phase 2 Meeting Presentation by FDA. Just to set people straight since some try to instill fear and doubt. Obviously Prana is well into this process.

    EOP 2 Meeting
    • Objectives:
    – To obtain agreement on pivotal study designs, and safety and efficacy endpoints for Phase 3 studies
    – To update on progress of PK studies and discuss additional studies needed
    – To assure that pre-clinical data with regard to duration, route of administration, and formulation are supportive of the dose to be used in clinical trials
    CMC
    – To discuss approach to specifications and test methods
    – To discuss “to be marketed” formulation
    – To evaluate appropriate protocols
    – To identify other issues or potential problems (novel regulatory or technical concerns)
    EOP2 meeting briefing package
    • Summaries of Phase 1 and Phase 2 investigations
    • Summary information on plans for Phase 3 trials
    • Specific protocols for Phase 3 studies
    • Plans for pediatric studies
    • Plans for additional non clinical studies (if required)
 
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