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

reuters ·  Oct 6, 2021 13:50

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;))

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