Item 7.01 Regulation FD Disclosure.
On
Based upon the above, the Company anticipates tentative approval of the FT218
NDA with potential full approval on or before the expiration of the REMS patent
on
The Company believes in the potential of FT218 and its importance to the narcolepsy community. The Company is committed to pursuing all options for FT218 to realize its full value.
Forward-Looking Statements
Statements contained under this Item 7.01 regarding matters that are not
historical facts are "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. These forward-looking statements relate to the Company's
future expectations, beliefs, plans, strategies, objectives, results,
conditions, financial performance, prospects, or other events. Such
forward-looking statements include, but are not limited to, expectations
regarding the timing and outcome of
Any forward-looking statements in this Current Report on Form 8-K are based on
estimates and assumptions that are made within the bounds of the Company's
knowledge of its business and operations and that it considers reasonable.
However, the Company's business and operations are subject to significant risks,
and, as a result, there can be no assurance that actual results and the results
of the Company's business and operations will not differ materially from the
results contemplated in such forward-looking statements. Factors that could
cause actual results to differ from expectations in the Company's
forward-looking statements include the risks and uncertainties described in the
"Risk Factors" section of Part I, Item 1A of the Company's Annual Report on
Form 10-K for the year ended
Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
The information furnished under this Item 7.01 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
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