Item 8.01 - Other Events.
On
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 plans to further engage
the FDA in the coming months to align on the remaining outstanding items related
to the additional Phase 3 clinical trial, 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 Company may not be able to
align with the FDA on the remaining outstanding items related to the additional
Phase 3 clinical trial, 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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