Brief: Axcella Announces Regulatory Path To Registration For Long Covid Fatigue treatment
23/01/2023 21:43
Jan 23 (Reuters) - Axcella Health Inc AXLA.O :
* AXCELLA ANNOUNCES REGULATORY PATH TO REGISTRATION OF
AXA1125 FOR
LONG COVID FATIGUE
* AXCELLA HEALTH INC - IND FOR PHASE 2B/3 TRIAL SUBMITTED TO
FDA
* AXCELLA HEALTH INC - MHRA GUIDANCE ALIGNS ON KEY
MEASUREMENTS
FOR A REGISTRATION TRIAL, INCLUDING PRIMARY ENDPOINT AND TRIAL
DESIGN ELEMENTS
* AXCELLA HEALTH INC - WILL BE MEETING WITH MHRA IN NEAR
TERM TO
DISCUSS INNOVATIVE LICENSING AND ACCESS PATHWAY (ILAP)
APPLICATION
Source text for Eikon: ID:nBw8y0kQ0a
Further company coverage: AXLA.O
((Reuters.Briefs@thomsonreuters.com;))
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