Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
As previously planned and disclosed,
Item 7.01 Regulation FD Disclosure.
On
A copy of the press release is furnished as Exhibit 99.1 hereto.
Item 8.01 Other Events.
On
In the complete response letter, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information will be needed to support regulatory approval. There were no chemistry, manufacturing and controls (CMC), safety, or non-clinical issues precluding approval raised in the complete response letter.
The Company plans to request a Type A meeting as soon as possible with FDA to discuss the complete response letter and determine the most expeditious path forward for the approval of narsoplimab in the treatment of HSCT-TMA.
This Current Report on Form 8-K contains 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, which are subject to the "safe harbor" created
by those sections for such statements. All statements other than statements of
historical fact are forward-looking statements, which are often indicated by
terms such as "anticipate," "believe," "could," "estimate," "expect," "goal,"
"intend," "likely," "look forward to," "may," "objective," "plan," "potential,"
"predict," "project," "should," "slate," "target," "will," "would" and similar
expressions and variations thereof. Forward-looking statements, including
expectations with regard to interactions and communications with FDA and the
Company's pursuit of regulatory approval for narsoplimab in HSCT-TMA, are based
on management's beliefs and assumptions and on information available to
management only as of the date of this press release. The Company's actual
results could differ materially from those anticipated in these forward-looking
statements for many reasons, including, without limitation, risks associated
with product commercialization and commercial operations, regulatory processes
and oversight, and the risks, uncertainties and other factors described under
the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed
with the
Item 9.01 Financial Statements and Exhibits. (d) Exhibits.
Exhibit Number Description 99.1 Press Release datedOctober 18, 2021 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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