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Biotech / Medical : ProMetic Life Sciences

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From: axial	10/16/2018 8:51:01 AM
	of 250

PROMETIC ANNOUNCES POSITIVE FEEDBACK FROM FDA TYPE-C MEETING ON RYPLAZIM (PLASMINOGEN) BLA Implementation plan for additional analytical assays and in-process controls confirmed Company finalizing process performance qualification (PPQ) protocol in order to proceed with the manufacturing of RYPLAZIM™ (plasminogen) conformance lots ' LAVAL, QUEBEC, CANADA, – October 16, 2018 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic” or the “Corporation”) announced today that it has completed a Type C meeting in which the FDA agreed with the Company’s proposed action plan for the implementation of additional analytical assays and in-process controls related to RyplazimTM (plasminogen) manufacturing process. As a result of the feedback received during the Type C meeting, Prometic is finalizing the process performance qualification (PPQ) protocol in anticipation of commencing the manufacturing of additional RyplazimTM (plasminogen) conformance lots. “We are pleased with the positive outcome of the Type C meeting regarding the plan that we submitted in response to the FDA’s list of items outlined in the CMC section of our RyplazimTM BLA,” said Bruce Pritchard, Chief Operating Officer and Chief Financial Officer of Prometic. “As a result of the feedback received, we will now continue with finalizing the remaining steps necessary to proceed with the running of RYPLAZIM™ conformance batches.” “We have worked diligently with our external regulatory consultants to ensure that our proposed CMC changes would be satisfactory to the FDA,” commented Pierre Laurin, President and Chief Executive Officer of Prometic. “We believe that it was prudent and appropriate to first validate our plan with the agency prior to proceeding with the running of the additional conformance lots. We will continue to proceed in a careful and methodical manner and will provide further updates to our shareholders during our regularly-scheduled quarterly results communications.” ' Jim

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