Item 8.01 - Other Events.
On January 18, 2021, Sesen Bio, Inc. (the "Company") completed an Assessment Aid
submission to the FDA in connection with the Company's Biologics License
Application ("BLA") for VicineumTM as part of a voluntary program developed by
the FDA's Oncology Center of Excellence. Following the Company's submission of
the BLA, the Company was selected to participate in the Assessment Aid program
as part of the BLA review process.
The Assessment Aid is based on the FDA Multidisciplinary Review template with
the main objectives of focusing the FDA review on the benefit-risk profile,
increasing efficiency to decrease review time and, should Vicineum be approved,
the Assessment Aid helps support the summary basis for approval.
In addition, the Company has been invited to participate in an FDA Application
Orientation Meeting (AOM) in late January 2021 in order to educate the FDA
review team on the BLA submission to further facilitate the FDA's review.
For more information on FDA programs designed to facilitate BLA/NDA review,
please refer to www.fda.gov.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, expectations regarding the FDA's review process and the
potential FDA approval of Vicineum. These forward-looking statements are based
on the Company's current expectations and inherently involve significant risks
and uncertainties. The Company's actual results and the timing of events could
differ materially from those anticipated in such forward-looking statements as a
result of these risks and uncertainties. A further description of the risks and
uncertainties relating to the business of the Company is contained in the
Company's most recent annual report on Form 10-K and the Company's quarterly
reports on Form 10-Q, as well as any amendments thereto reflected in subsequent
filings with the SEC. The Company undertakes no duty or obligation to update any
forward-looking statements contained in this report as a result of new
information, future events or changes in its expectations.
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