Item 7.01 - Regulation FD Disclosure.
On
As the Company prepares for the Type B Meeting, and evaluates an additional Phase 3 clinical trial, it will continue the process to review strategic alternatives with the goal of maximizing shareholder value.
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 an additional Phase 3 clinical trial
that the Company is evaluating for potential resubmission of a BLA for Vicineum
for the treatment of NMIBC and the Company's plans to continue the process to
review strategic alternatives with the goal of maximizing shareholder value,
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 request for a Type B Meeting may not occur within the anticipated timing, or
at all, the risk that the Type B Meeting may not enable the Company to align
with the FDA on the remaining outstanding items related to an additional Phase 3
clinical trial of Vicineum for the treatment of NMIBC, the risk that the Company
may not continue its plans to conduct an additional Phase 3 clinical trial and
pursue regulatory approval for Vicineum for the treatment of NMIBC in the US,
the risk that an additional Phase 3 clinical trial of Vicineum for the treatment
of NMIBC may fail to demonstrate safety and efficacy to the satisfaction of the
FDA, or otherwise produce favorable results, the risk that the FDA may not
approve the BLA for Vicineum for the treatment NMIBC if the Company resubmits
the BLA at a future time, the risk that Vicineum for the treatment of 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, limit the commercial profile of its labeling, if approved,
or result in significant negative consequences following any marketing approval,
the risk that the Company may pursue one or more strategic alternatives instead
of pursuing an additional Phase 3 clinical trial and the risk that the Company
may not be successful in identifying one or more strategic alternatives or
ultimately pursuing a strategic alternative that delivers the anticipated
benefits or enhances shareholder value, 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
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