Item 8.01 Other Events.
On
A copy of the Company's press release is filed with this Report as Exhibit 99.1.
Forward Looking Statements
This Current Report on Form 8-K, and the press release filed as an exhibit with
this Report, contain forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include those that express plans, anticipation, intent,
contingencies, goals, targets or future development and/or otherwise are not
statements of historical fact. These statements relate to future events or
future results of operations, including, but not limited to the following
statements: the opinions and beliefs of the Company and third parties concerning
the potential of Tempol as a treatment for COVID-19 and the results of previous
studies of Tempol; the Company's beliefs concerning the safety and effectiveness
of Tempol or the Company's other product candidates; the timing, progress or
results of the Company's Phase 2/3 clinical trial for Tempol or other studies or
trials relating to Tempol; the Company's beliefs concerning the outcome of its
Fast Track application to the FDA relating to Tempol; the Company's ability to
commercialize its product candidates, itself or through commercialization
partners; the Company's beliefs concerning the benefits, enforceability, and
extent of intellectual property rights and protection afforded by patents and
patent applications that it owns or has licensed; and other statements
concerning the Company's future operations and activities. These statements are
only predictions and involve known and unknown risks, uncertainties, and other
factors, which may cause the Company's actual results to be materially different
from the results anticipated by such forward-looking statements. There are no
assurances that the FDA will grant Fast Track designation for the Company's
Tempol product candidate. There can be no assurances regarding the timing,
progress or outcome of trials or studies relating to Tempol, or that Tempol will
be found to be safe and effective in the treatment of COVID-19 or any other
indication. We cannot assess the impact of each factor on our business or the
extent to which any factor, or combination of factors, may cause actual results
to differ materially from those contained in any forward-looking statements. You
should not place undue reliance on any forward-looking statements. Further, any
forward-looking statement speaks only as of the date on which it is made, and
except as may be required by applicable law, we undertake no obligation to
update or release publicly the results of any revisions to these forward-looking
statements or to reflect events or circumstances arising after the date of this
Report. Certain of these risks and additional risks, uncertainties, and other
factors are described in greater detail in the Company's filings from time to
time with the
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