Brief: Erytech Requests Pre-BLA Meeting With FDA To Discuss Path To Approval In ALL

Phaxiam Therapeutics SA

20/04/2021 06:39

April 20 (Reuters) - ERYTECH PHARMA SA  ERYP.PA :
    * REG-ERYTECH REQUESTED A PRE-BLA MEETING WITH THE FDA TO
DISCUSS
PATH TO APPROVAL IN ALL
    * ERYTECH INVITED BY FDA TO REQUEST A PRE-BLA MEETING
    * FIRST STEP IN MARKETING APPROVAL PROCESS WITH FDA FOR
ERYASPASE
FOR TREATMENT OF HYPERSENSITIVE ALL PATIENTS BASED ON POSITIVE
RESULTS OF NOPHO-SPONSORED PHASE 2 CLINICAL TRIAL
    * PLANS TO SUBMIT A BIOLOGICS LICENSE APPLICATION (BLA) IN
SECOND
HALF OF 2021 FOR ITS LEAD PRODUCT CANDIDATE ERYASPASE

Source text for Eikon:  ID:nGNEbG1tm5 
Further company coverage:  ERYP.PA 

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