Item 8.01 – Other Events.
On December 14, 2020, Sesen Bio, Inc. (the “Company”) had its second of two successful meetings with the assigned Rapporteurs, following the first meeting on November 2, 2020, to discuss the upcoming marketing authorization application (“MAA”) for Vicineum™, the Company’s lead product candidate.1
The Rapporteurs are members of the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) who jointly coordinate the CHMP’s evaluation of the Company’s planned MAA. During the meetings, the Company received guidance on the contents of the MAA, further refining the path to potential approval in Europe.
The successful meetings with the Rapporteurs are the final material step in completing all pre-submission activities for the MAA for Vicineum, which the Company expects to submit to the EMA in early 2021.
The Company also remains on track to submit its Biologics License Application to the United States Food and Drug Administration (“FDA”) later this month and has been in close contact with the FDA to discuss the timing of the pre-license inspection.
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1The proprietary brand name, Vicineum, is a corporate trademark which has been conditionally approved by the FDA. Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate, oportuzumab monatox. The Company is currently going through the tradename approval process in Europe for oportuzumab monatox.
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