Brief: Ortho Regenerative Technologies Announces Successful Type A Meeting With U.S. FDA On CMC Elements

Chitogenx

06/10/2021 18:48

Oct 6 (Reuters) - Ortho Regenerative Technologies Inc
 ORTH.CD :
    * ORTHO REGENERATIVE TECHNOLOGIES ANNOUNCES SUCCESSFUL TYPE
A
MEETING WITH U.S. FDA ON CMC ELEMENTS FOR WHICH MORE INFORMATION
WAS REQUIRED TO CLEAR IND CLINICAL HOLD
    * ORTHO REGENERATIVE TECHNOLOGIES INC - AGREEMENT REACHED
WITH FDA
ON ELEMENTAL IMPURITY TESTING USING SELECTED STANDARD REFERENCE
MATERIAL
    * ORTHO REGENERATIVE TECHNOLOGIES INC - WILL PROVIDE
PROTOCOL AND
TESTING RESULTS DURING COMING WEEKS
    * ORTHO REGENERATIVE TECHNOLOGIES INC - PATIENT ENROLMENT
STILL
EXPECTED TO START BY YEAR END
    * ORTHO REGENERATIVE TECHNOLOGIES - FDA HAS CONFIRMED
CLINICAL
HOLD WILL  BE CLEARED WITHIN 30 DAYS OF SUBMISSION OF PROTOCOL
AND TESTING RESULTS

Source text for Eikon:  ID:nCNWNg8pna 
Further company coverage:  ORTH.CD 

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