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PATH > SEC Filings for PATH > Form 8-K on 30-Aug-2011All Recent SEC Filings

Show all filings for NUPATHE INC.

Form 8-K for NUPATHE INC.


30-Aug-2011

Regulation FD Disclosure, Other Events, Financial Statements and Exhibits


Item 7.01 Regulation FD Disclosure.

On August 30, 2011, NuPathe Inc. issued a press release announcing that it received a Complete Response Letter from the U.S. Food & Drug Administration regarding the New Drug Application for its migraine patch (also referred to as NP101 or Zelrix). A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated by reference into this Item 7.01.



Item 8.01 Other Events.

On August 29, 2011, NuPathe Inc. (the "Company") received a Complete Response Letter ("CRL") from the U.S. Food & Drug Administration ("FDA") regarding the New Drug Application ("NDA") for its migraine patch (also referred to as "NP101" or "Zelrix"). A CRL is issued by the FDA's Center for Drug Evaluation and Research when the review of an NDA is completed and questions remain that preclude the FDA from approving the NDA at the time. The Company intends to request an End-of-Review meeting with the FDA to discuss the issues cited in the CRL and the Company's approach to resolving them. The issuance of this CRL means that the Company will not launch its migraine patch in the first half of 2012, as previously expected.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. Description of Exhibit

99.1 Press release issued by NuPathe Inc. on August 30, 2011

* * * * *

The information contained in Item 7.01, Item 9.01 and Exhibit 99.1 of this Form 8-K are being "furnished" to the Securities and Exchange Commission. Neither the information contained in Item 7.01, nor Item 9.01 nor Exhibit 99.1 shall be incorporated by reference into any filings of NuPathe Inc. under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated into such filing by specific reference to the "furnished" information contained herein.


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