Item 7.01. Regulation FD Disclosure
On
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K, including Exhibit 99.1, contains
forward-looking statements. Forward-looking statements reflect management's
current knowledge, assumptions, judgment and expectations regarding future
performance or events. Although management believes that the expectations
reflected in such statements are reasonable, they give no assurance that such
expectations will prove to be correct and you should be aware that actual events
or results may differ materially from those contained in the forward-looking
statements. Words such as "will," "expect," "intend," "plan," "potential,"
"possible," "goals," "accelerate," "continue," and similar expressions identify
forward-looking statements, including, without limitation, statements regarding
the sufficiency of the data from the ACTIV-5/BET-B study to warrant a future
submission of a new EUA request; statements regarding the Company's efforts to
request and receive Marketing Authorization or Conditional Marketing
Authorization for lenzilumab in COVID-19 in the
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this filing. The Company undertakes no obligation to revise or update any forward-looking statements made in this filing to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.
Certain Information
The information in this Item 7.01, including Exhibit 99.1, is being furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company's filings under the Securities Act of 1933, as amended, except to the extent expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Exhibit No. Exhibit Description
99.1
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
© Edgar Online, source