Item 7.01 - Regulation FD Disclosure.
On November 17, 2021, the US Food & Drug Administration ("FDA") granted Sesen
Bio, Inc.'s (the "Company") request for a Type A meeting (the "Clinical Type A
Meeting") to discuss recommendations specific to additional clinical/statistical
data and analyses raised in the FDA's Complete Response Letter ("CRL") regarding
the Company's Biologics License Application ("BLA") for VicineumTM for the
treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC"). The
Clinical Type A Meeting has been scheduled for December 8, 2021 and follows the
Type A Meeting held on October 29, 2021 during which the Company and the FDA
reviewed issues related to Chemistry, Manufacturing and Controls ("CMC") raised
in the CRL (the "CMC Type A Meeting").
As previously disclosed, the Company intends to use the information from both
the upcoming Clinical Type A Meeting and the CMC Type A Meeting to synchronize
the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC
in the US and the European Union. The Company looks forward to continuing to
work collaboratively with regulators to determine the appropriate path forward.
The information furnished in this Item 7.01 shall not be deemed to be "filed"
for the purposes of Section 18 of the Securities and Exchange Act of 1934, as
amended (the "Exchange Act"), or otherwise subject to the liabilities of such
section, nor shall such information be deemed incorporated by reference into any
filing under the Securities Act of 1933, as amended, or the Exchange Act, except
as shall be expressly set forth by specific reference in such a filing.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, statements regarding the Company's intentions to use
information from both the upcoming Clinical Type A Meeting and the CMC Type A
Meeting to synchronize the regulatory reviews of Vicineum for the treatment of
BCG-unresponsive NMIBC in the US and the European Union and the Company's plans
to continue to work collaboratively with regulators to determine the appropriate
path forward, which 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,
including the risk that the Clinical Type A Meeting may not occur within the
anticipated timing, or at all, the risk that the CMC Type A Meeting and the
Clinical Type A Meeting may not enable the Company to synchronize the regulatory
reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and
the European Union, the Company may not resume its plans to pursue regulatory
approval for Vicineum for the treatment of BCG-unresponsive NMIBC in the US or
the European Union, the risk that clinical trials of Vicineum for the treatment
of BCG-unresponsive NMIBC may fail to demonstrate safety and efficacy to the
satisfaction of the FDA or the European Medicines Agency, or otherwise produce
favorable results, the risk that the FDA may not approve the BLA for Vicineum
for the treatment of BCG-unresponsive NMIBC if the Company resubmits the BLA at
a future time, the risk that the European Commission may not approve the
Company's marketing authorization application ("MAA") for Vicineum for the
treatment of BCG-unresponsive NMIBC if the Company resubmits the MAA at a future
time, and the risk that Vicineum for the treatment of BCG-unresponsive NMIBC may
cause undesirable side effects, serious adverse events or have other properties
that could delay or halt clinical trials, delay or prevent its regulatory
approval by the FDA or the European Commission, limit the commercial profile of
its labeling, if approved, or result in significant negative consequences
following any marketing approval, among other 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 Securities and Exchange Commission. 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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