Sesen Bio Announces Acceptance of Analytical Comparability Plan by the U.S. Food and Drug Administration to Support the BLA and Commercialization of Its Lead Asset, Vicinium® for Non-Muscl...
Sesen Bio, Inc. (SESN)
Last sesen bio, inc. earnings: 11/12 07:00 am
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Source: Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that the Company has completed its Type C CMC meeting and has reached agreement with the U.S. Food and Drug Administration (FDA) on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time. In its Phase 2 and 3 clinical trials, Sesen Bio manufactured Vicinium in its facility in Winnipeg, Manitoba. Based on the Company’s assessment of the global demand potential for Vicinium, Sesen Bio sought a commercial manufacturer with outstanding manufacturing quality, a proven track record with regulatory agencies, and the capacity to meet global demand forecasts.
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