Brief: Vivani Medical Inc - On August 11, FDA Provided Verbal Notice That Liberate-1 Study Was Placed On Clinical Hold

Vivani Medical

29/08/2023 11:16

Aug 29 (Reuters) - Vivani Medical Inc  VANI.O :
    * VIVANI MEDICAL INC -  ON AUGUST 11, FDA PROVIDED VERBAL
NOTICE
THAT LIBERATE-1 STUDY WAS PLACED ON CLINICAL HOLD
    * VIVANI MEDICAL -  ON AUG 18, FDA GAVE FORMAL FULL CLINICAL
HOLD
CORRESPONDENCE STATING INSUFFICIENT CMC INFORMATION TO ASSESS
RISKS TO HUMAN SUBJECTS
    * VIVANI MEDICAL INC - ON AUGUST 25, CO PROVIDED A COMPLETE
RESPONSE TO FDA
    * VIVANI MEDICAL INC -  CO'S CR INCLUDES ADDITIONAL
INFORMATION,
COMMITMENTS TO OBTAIN SUPPLEMENTAL INFORMATION IN PARALLEL WITH
CONDUCT OF LIBERATE-1
    * VIVANI MEDICAL -IF CR ADEQUATE, CLINICAL HOLD LIFTED, SEES
STARTING LIBERATE-1 IN OCT 2023, INTERIM RESULTS IN 1H2024, FULL
TOP-LINE RESULTS IN 2H2024
    * VIVANI MEDICAL INC -IF CR DEEMED INADEQUATE, SEES
ADDITIONAL IN
VITRO DATA MAY ENABLE IND CLEARANCE, CAUSE A DELAY TO TIMELINE
GUIDANCE BY ABOUT 1 QUARTER

Source: [https://shorturl.at/inwH3]
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