Item 8.01 Other Events.
On February 14, 2023, in a press release, Delcath Systems,
Inc. (the “Company”) announced that it had filed a New Drug
Application (“NDA”) resubmission to the U.S. Food and Drug
Administration (“FDA”) for the HEPZATO™ Kit (melphalan
hydrochloride for Injection/Hepatic Delivery System) in the
treatment of patients with unresectable hepatic-dominant metastatic
ocular melanoma (mOM).
The Company expects that, within the next 30 days, the FDA will
determine whether the NDA resubmission constitutes a complete
response to a September 12, 2013 Complete Response Letter
(CRL) from the FDA and is accepted for review by the FDA. Once the
NDA is accepted for review by the FDA, the Company expects a
Prescription Drug User Fee Act target action date will be
established for the HEPZATO Kit and communicated to the
Company.
The full text of the press release is attached as Exhibit 99.1 and
incorporated in this Item 8.01 by reference.
Forward-Looking Statements
This Current Report on Form 8-K and Exhibit 99.1 hereto contain
“forward-looking statements”. Forward-looking statements can
generally be identified by the use of words such as “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “forecast,”
“intend,” “may,” “plan,” “project,” “potential,” “seek,” “should,”
“think,” “will,” “would” and similar expressions, or they may use
future dates. Such forward-looking statements include, without
limitation, statements regarding the Company’s expectations as to
the FDA’s handling of the Company’s NDA. These forward-looking
statements are based on current expectations and subject to
assumptions, risks and uncertainties that may change at any time,
and readers are therefore cautioned not to place undue reliance on
any forward-looking statements as there are important factors that
could cause actual results to differ materially from those
expressed in any forward-looking statements. No forward-looking
statement can be guaranteed. Among the factors that could cause
actual results to differ materially from those indicated in the
forward-looking statements are risks and uncertainties associated
with the regulatory review and approval process. There is no
guarantee that the FDA will accept for filing the Company’s NDA for
the HEPZATO Kit or that HEPZATO Kit will be approved by the FDA.
Factors that could cause actual results to differ include, among
other things: the FDA’s satisfaction with the Company’s NDA; the
FDA’s timeframe for analyzing and responding to the NDA; the
Company’s ability to respond to FDA queries; the results of
inspections by the FDA; and other risks and uncertainties discussed
in the Company’s filings with the SEC, including under the “Risk
Factors” sections of the Company’s Annual Report on Form
10-K for the fiscal year
ended December 31, 2021. The Company undertakes no obligation
to update any forward-looking statements as a result of new
information, future developments or otherwise, except as expressly
required by law. All forward-looking statements in this document
are qualified in their entirety by this cautionary statement.
Item 9.01. Financial Statements and Exhibits.