Brief: Medicenna Provides MDNA55 Rgbm Clinical Program Update Following Positive End Of Phase 2 Meeting With The U.S. Food And Drug Administration

Medicenna Therapeutics

15/10/2020 22:37

Oct 15 (Reuters) - Medicenna Therapeutics Corp  MDNA.TO :
    * MEDICENNA PROVIDES MDNA55 RGBM CLINICAL PROGRAM UPDATE
FOLLOWING
POSITIVE END OF PHASE 2 MEETING WITH THE U.S. FOOD AND DRUG
ADMINISTRATION (FDA)
    * MEDICENNA THERAPEUTICS CORP - AFTER CONSULTATION WITH FDA,
COMPANY CAN CONDUCT A HYBRID REGISTRATION TRIAL
    * MEDICENNA - REDUCED ENROLLMENT REQUIREMENTS IN CONTROL ARM
CAN
SUBSTANTIALLY LOWER TRIAL COSTS AND EXPEDITE TIMELINES FOR
REGULATORY APPROVAL IN RGBM
    * MEDICENNA THERAPEUTICS CORP - FDA HAS ALSO EXPRESSED A
WILLINGNESS TO POSSIBLY CONSIDER AN INTERIM ANALYSIS OF TRIAL IF
CERTAIN CRITERIA ARE MET.
    * MEDICENNA - ADVISED TO PROCEED WITH AN INNOVATIVE
OPEN-LABEL
HYBRID CONTROL DESIGN FOR A PHASE 3 REGISTRATION TRIAL OF MDNA55
IN RGBM PATIENTS

Source text for Eikon:  ID:nGNXc0TntC 
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