Gamida Cell Ltd
NASDAQ:GMDA 4:00:00 PM EDT
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.
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.