RE:dont ask me where i got this, it's a secret (q3 baby)On March 28, 2018, the name of the company was Prometic Life Science.
Another distorsion of reality made in Thomvest.
LOL
Genius.
Newcamo wrote: On March 28, 2018, Liminal BioSciences provided an update on the status of the FDA review of its BLA for Ryplazim®, and subsequently the FDA issued a Complete Response Letter (“CRL”). The FDA identified the need for Liminal BioSciences to make a number of changes in the Chemistry Manufacturing and Controls (“CMC”) section. These require the implementation and validation of additional analytical assays and “in-process controls” in the manufacturing process of Ryplazim®. Once completed and validated, Liminal BioSciences is required to manufacture additional Ryplazim® conformance batches to confirm the effectiveness of these process changes.
The FDA has indicated that the submission of the amended BLA for Ryplazim® will not impact the previously granted designations, including the Priority Review Status, the Orphan Drug Designation and the Rare Pediatric Disease Designation for Ryplazim® for the treatment of PLDG.
The Company expects to be filing an amendment to the BLA in Q3 2020 .