The Corporation focussed on the biology of healing this week announced positive feedback from the FDA type-c meeting on the Ryplazim™ (plasminogen) BLA (biologics license application). We are reassured by the FDA’s agreement with the Company’s proposed action plan for the implementation of additional analytical assays and in-process controls related to the Ryplazim™ (plasminogen) manufacturing process.
18 Oct 2018
RYPLAZIM™ - FDA agrees action plan to satisfy items regarding manufacturing process
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RYPLAZIM™ - FDA agrees action plan to satisfy items regarding manufacturing process
ProMetic Life Sciences (PLI:TSE) | 0 0 1.3% | Mkt Cap: 1,075m
- Published:
18 Oct 2018 -
Author:
Derren Nathan -
Pages:
7
The Corporation focussed on the biology of healing this week announced positive feedback from the FDA type-c meeting on the Ryplazim™ (plasminogen) BLA (biologics license application). We are reassured by the FDA’s agreement with the Company’s proposed action plan for the implementation of additional analytical assays and in-process controls related to the Ryplazim™ (plasminogen) manufacturing process.