UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) October 23, 2006
REPLIDYNE, INC.
(Exact name of registrant as specified in its charter)
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| Delaware
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000-52082
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84-1568247 |
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(Commission File Number)
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(I.R.S. Employer |
| incorporation or organization)
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Identification No.) |
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| 1450 Infinite Drive,
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80026 |
| Louisville, Colorado
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(Zip Code) |
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720-996-5500
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
INFORMATION TO BE INCLUDED IN THE REPORT
Section 7 — Regulation FD
Item 7.01 Regulation FD Disclosure.
On October 23, 2006, Replidyne, Inc. (the “Company”) issued a press release announcing that the
U.S. Food and Drug Administration (“FDA”) has issued a
non-approval letter for the Company’s new drug application for
faropenem medoxomil that was submitted to the FDA in Decmeber 2005. A copy of the press release is furnished as Exhibit 99.1 to this Form
8-K.
In accordance with General Instruction B.2. of Form 8-K, the information presented under this Item
7.01 and attached as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in
any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific
reference in such a filing.
Section 9 — Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
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99.1
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Press Release, dated October 23, 2006, Entitled “U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem.” |