Brief: Atossa Therapeutics Plans To Complete Required Ongoing Studies And Submit Information Required By FDA By End Of Q3 2022

Atossa Therapeutics

01/07/2022 14:07

July 1 (Reuters) - Atossa Therapeutics Inc  ATOS.O :
    * ATOSSA THERAPEUTICS - PLANS TO COMPLETE REQUIRED ONGOING
STUDIES
AND SUBMIT INFORMATION REQUIRED BY FDA BY END OF Q3 2022
    * ATOSSA THERAPEUTICS - PLANS TO INITIATE ENROLLMENT INTO
NEOADJUVANT STUDY, ON SCHEDULE, IN Q4 2022
    * ATOSSA - UNLESS REQUIRED INFORMATION, ADDITIONAL
INFORMATION FDA
MAY NEED, CAN BE PROVIDED NEOADJUVANT STUDY IS ON CLINICAL HOLD
& CANNOT COMMENCE
    * ATOSSA - CONTINUES TO RECRUIT PARTICIPANTS FOR PHASE 2
CLINICAL
STUDY OF (Z)-ENDOXIFEN IN PREMENOPAUSAL WOMEN WITH MEASURABLE
BREAST DENSITY IN SWEDEN
    * ATOSSA THERAPEUTICS - FDA COMMUNICATED THAT IND FOR 
NEOADJUVANT
STUDY REQUIRES SOME ADDITIONAL STABILITY DATA CONCERNING DRUG
PRODUCT
    * ATOSSA THERAPEUTICS - FDA COMMUNICATED TO CO THAT IND ALSO
REQUIRES NON-SIGNIFICANT REVISIONS TO NEOADJUVANT STUDY PROTOCOL
& INFORMED CONSENT FORM

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