Brief: Kamada announces FDA acceptance of Inhaled AAT program path forward

Kamada

16/04/2019 12:20

April 16 (Reuters) - Kamada Ltd  KMDA.TA :
    * KAMADA ANNOUNCES FDA ACCEPTANCE OF INHALED AAT PROGRAM
PATH
FORWARD
    * KAMADA LTD - RECEIPT OF A LETTER FROM U.S. FOOD AND DRUG
ADMINISTRATION
    * KAMADA LTD - EXPECTS TO INITIATE PHASE 3 STUDY DURING
SECOND
HALF OF 2019
    * KAMADA LTD - FDA STATED COMPANY HAS SATISFACTORILY
ADDRESSED
CONCERNS AND QUESTIONS REGARDING ITS INHALED ALPHA-1-ANTITRYPSIN
(INHALED AAT) PROGRAM
    * KAMADA LTD - RECENT RESPONSE FROM FDA IN CONNECTION WITH
DEVELOPMENT PLAN FOR INHALED AAT FOLLOWS POSITIVE SCIENTIFIC
ADVICE RECEIVED IN JULY 2018
    * KAMADA LTD - KAMADA INTENDS TO CONDUCT A UNIFIED GLOBAL
PIVOTAL
PHASE 3 CLINICAL TRIAL IN U.S. UNDER AN INVESTIGATIONAL NEW DRUG
APPLICATION
    * KAMADA ANNOUNCES FDA ACCEPTANCE OF INHALED AAT PROGRAM
PATH
FORWARD

Source text for Eikon:  ID:nGNX3F0JC6 
Further company coverage:  KMDA.TA 

 ((Reuters.Briefs@thomsonreuters.com;))