Gamida Cell Ltd

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Products, Regulatory

Gamida Cell Intends To File Marketing Application For Omidubicel In H2 Of 2021

Published: 12/14/2020 12:26 GMT
Gamida Cell Ltd (GMDA) - Conducted a Type B Meeting for Omidubicel With U.S. Food and Drug Administration (fda) on Friday, December 11, 2020.
FDA Recommended Gamida Cell Generate Additional Manufacturing-related Data Prior to Requesting a Pre-biologics License Application (bla) Meeting.
FDA Requested Gamida Demonstrate Analytical and Clinical Comparability From Company's Planned Commercial Manufacturing Sites.
Gamida Cell - Intends to Submit Full Bla for Omidubicel in H2 of 2021 in Lieu of Co's Previous Plan to Initiate Rolling Bla Submission by End of 2020.