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Item 7.01
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Regulation FD Disclosure.
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As reported in a Current Report on Form 8-K filed with the SEC
on July 15, 2016, on July 15, 2016, Elite Pharmaceuticals, Inc., or Elite, announced that the U.S. Food and Drug Administration,
or the FDA, issued a Complete Response Letter, or CRL, regarding the New Drug Application, or NDA, for SequestOx™ (oxycodone
hydrochloride and naltrexone hydrochloride), Elite’s investigational abuse-deterrent opioid candidate for the management
of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The CRL indicated that the review cycle for
the SequestOx NDA is complete and the application is not ready for approval in its present form.
On July 18, 2016, Elite held a conference call to provide more
detail about the CRL.
A copy of the transcript of that call is furnished as Exhibit
99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the transcript furnished
as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings under the Securities Act
of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall
be expressly set forth by specific reference in any such filing.
Caution Concerning Forward Looking Statements
This Current Report contains “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on
future results, performance or other expectations that may have some correlation to the subject matter of this Current Report,
readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, Elite’s
ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability
to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or
achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these
forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval,
if at all, of SequestOx™ by the FDA, the steps Elite may take as a result of the CRL, the results of an End of Review Meeting
and what actions the FDA may require of Elite in order to obtain approval of the NDA. These forward-looking statements are not
guarantees of future action or performance. These risks and other factors, including, without limitation, Elite’s ability
to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical
trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property
protections and defenses, and the Elite’s ability to operate as a going concern, are discussed in Elite's filings with the
Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or
alter its forward-looking statements, whether as a result of new information, future events or otherwise.