Some ten months after submission, ProMetic Life Sciences has today announced that the FDA has cleared its Investigational New Drug application for IVIG (intravenous immunoglobulin) for the treatment of primary immunodeficiency diseases (PIDD). Despite the relatively long approval period, ProMetic is well prepared to move quickly with the majority of clinical sites for the proposed pivotal Phase III study already prepared. We understand the target date for first sales remains 2018. Given that
26 Oct 2015
IND granted for IVIG. Phase III next
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IND granted for IVIG. Phase III next
ProMetic Life Sciences (PLI:TSE) | 0 0 1.3% | Mkt Cap: 1,075m
- Published:
26 Oct 2015 -
Author:
Derren Nathan -
Pages:
7
Some ten months after submission, ProMetic Life Sciences has today announced that the FDA has cleared its Investigational New Drug application for IVIG (intravenous immunoglobulin) for the treatment of primary immunodeficiency diseases (PIDD). Despite the relatively long approval period, ProMetic is well prepared to move quickly with the majority of clinical sites for the proposed pivotal Phase III study already prepared. We understand the target date for first sales remains 2018. Given that