Item 8.01Other Events.
On January 21, 2020, Evoke Pharma, Inc. (the "Company") announced that the U.S.
Food and Drug Administration ("FDA") has accepted the Company's resubmission of
its 505(b)(2) New Drug Application ("NDA") for Gimoti™, the Company's nasal
spray product candidate for the relief of symptoms in adult women with acute and
recurrent diabetic gastroparesis.
A six-month period of review from the FDA's date of receipt has been assigned
for the resubmitted NDA and the application has been assigned a new Prescription
Drug User Fee Act ("PDUFA") target goal date of June 19, 2020.
Safe Harbor Statement
The Company cautions you that statements included in this report that are not a
description of historical facts are forward-looking statements. In some cases,
you can identify forward-looking statements by terms such as "may," "will,"
"should," "expect," "plan," "anticipate," "could," "intend," "target,"
"project," "contemplates," "believes," "estimates," "predicts," "potential" or
"continue" or the negatives of these terms or other similar expressions. These
statements are based on the Company's current beliefs and expectations. These
forward-looking statements include statements regarding: the timing and results
of any decision regarding the NDA from the FDA, including whether FDA will act
by the PDUFA target goal date; the Company's belief that Gimoti, if approved,
can fill an unmet medical need for the management of diabetic gastroparesis and
improve the quality of life for patients suffering from the disease; and the
Company's plans to focus on commercial readiness. The inclusion of
forward-looking statements should not be regarded as a representation by the
Company that any of its plans will be achieved. Actual results may differ from
those set forth in this press release due to the risks and uncertainties
inherent in the Company's business, including, without limitation: the potential
for the FDA to delay the PDUFA target goal date due to the FDA's internal
resource constraints or other reasons; the Company may be unable to timely and
successfully address the deficiencies raised in the Complete Response Letter
("CRL") regarding Gimoti, including as a result of adverse findings from a root
cause analysis or data from the newly manufactured product batches not fully
addressing issues raised by the FDA in the CRL and type A meeting; FDA may not
agree with the Company's conclusion of the results from the manufacturing
testing or the root cause analysis, or may require the Company to conduct
additional studies; further analysis of the manufacturing data; the FDA may
later determine to hold an advisory committee meeting and risks associated
therewith; the inherent risks of clinical development and regulatory approval of
Gimoti; the Company's dependence on third parties for the manufacture of Gimoti
and analysis of the manufacturing data; the Company is entirely dependent on the
success of Gimoti; the Company will require substantial additional funding to
continue its operations into the second quarter of 2020, and may be unable to
raise capital or obtain funds when needed, including to fund ongoing operations;
the Company could face significant additional costs due to litigation or other
events; the Company's ability to maintain the continued listing of its common
stock on the Nasdaq Capital Market; and other risks detailed in the Company's
prior reports it files with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forwardlooking statements, which
speak only as of the date hereof, and the Company undertakes no obligation to
revise or update this report to reflect events or circumstances after the date
hereof. All forward-looking statements are qualified in their entirety by this
cautionary statement. This caution is made under the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995.
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses