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| SCMP > SEC Filings for SCMP > Form 8-K on 3-Dec-2012 | All Recent SEC Filings |
3-Dec-2012
Regulation FD Disclosure, Other Events, Financial Statements and Ex
On December 4 and 5, 2012, Sucampo Pharmaceuticals, Inc. (the "Company") will make a corporate update presentation with one-on-one meetings with investors in Boston, MA that will include written communication comprised of slides.
The information in this Item 7.01 and Exhibit 99.1 to this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
The Company announced today that the U.S. Food and Drug Administration ("FDA") has extended the Prescription Drug User Fee Act ("PDUFA") goal date for the Agency's priority review of the supplemental new drug application filing seeking approval for an additional indication for lubiprostone for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain. Sucampo was notified that its November 16, 2012 submission of FDA-requested -supporting analyses has been designated as a major amendment to the application. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has decided to extend the goal date by three months to provide time for a full review of the submission. The extended user fee goal date is late April, 2013. No new clinical trials or studies have been requested by the FDA.
The information in this Item 8.01 and Exhibit 99.2 to this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
(d) Exhibits
The following exhibit relating to Item 8.01 shall be deemed to be furnished, and not filed:
99.1 The corporate update presentation slides dated December 4-5, 2012.
99.2 Press Release issued by the registrant on November 30, 2012.
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