Followers | 129 |
Posts | 2150 |
Boards Moderated | 1 |
Alias Born | 12/27/2007 |
Wednesday, November 04, 2015 9:34:39 AM
REALLY then why FDA says that Telesta can file BLA on existing clinical trial data set ???????
MCNA U.S. Regulatory Update
Following several months of active dialogue with the U.S. Food and Drug Administration (FDA), concerning the most appropriate regulatory pathway for MCNA approval in the United States, Bioniche has received written guidance. This guidance provides
regulatory clarity and permits the submission of an MCNA Biological License Application (BLA) for U.S. marketing approval review based on Bioniche's existing clinical trial data set.
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM