In process controls implementation date?Anybody question PLI on status of implementation date for "in process controls"? Perhaps I missed this.
Anyway, I just emailed Fred.
More delays?
Q4 report: - These changes require the implementation and validation of additional analytical assays and “in-process controls” in the manufacturing process of RYPLAZIM™ (plasminogen). While Prometic is expecting to complete said implementation and validation in April 2018, it will be necessary to manufacture additional RYPLAZIM™ (plasminogen) lots to support the implementation and validation of these process changes.
Today’s NR ·
For its lead plasma derived drug candidate RyplazimTM (plasminogen), ProMetic anticipates to: · Complete the implementation and validation of additional analytical assays and “in-process controls” in the manufacturing process of Ryplazim™ (plasminogen);