Brief: Egetis To Submit Authorisation Application For Emcitate

Egetis Therapeutics AB (publ)

13/12/2021 07:05

Dec 13 (Reuters) - Egetis Therapeutics AB (publ)  EGTX.ST :
    * EGETIS INTENDS TO SUBMIT A MARKETING AUTHORISATION
APPLICATION
FOR EMCITATE® TO THE EUROPEAN MEDICINES AGENCY BASED ON EXISTING
CLINICAL DATA
    * EGETIS CONCLUDES, BASED ON RECENT REGULATORY INTERACTIONS,
THAT
AVAILABLE TRIAC TRIAL I DATA TOGETHER WITH RECENTLY PUBLISHED
LONG-TERM DATA ARE SUFFICIENT FOR A MARKETING AUTHORISATION
APPLICATION IN EUROPE
    * HAVING ALL CLINICAL DATA REQUIRED FOR REGULATORY
SUBMISSION
ALREADY AT HAND SIGNIFICANTLY REDUCES REMAINING RISK FOR
EMCITATE
    * REVISED SUBMISSION TIMELINES WILL BE COMMUNICATED AS SOON
AS ALL
PARTS OF REGULATORY DOSSIER ARE CONFIRMED

Source text for Eikon:  ID:nMFN3r5cQ2 
Further company coverage:  EGTX.ST 

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