UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
Delaware | 001-32177 | 22-2407152 | ||||||
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(State or other jurisdiction | (Commission File No.) | (I.R.S. Employer | ||||||
of incoporation) | Identification No.) |
25 Minneakoning Road
Flemington, New Jersey 08822
(Address of principal executive offices) (Zip Code)
(908) 782-3431
(Registrants telephone number, including area code)
N/A
(Former name or former address, 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 (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
On October 19, 2005, NovaDel Pharma Inc. (the Company) issued a press release to announce that the Company would present at the CE Unterberg Towbin Emerging Growth LifeSciences Conference on October 26, 2005, in New York City. Dr. Gary Shangold, the Companys Chief Executive Officer, will provide a corporate overview, including an update on NovaDels product pipeline. The full text of Dr. Shangolds presentation is attached hereto as Exhibit 99.1 and the full text of the press release is attached hereto as Exhibit 99.2. The information furnished pursuant to this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, shall not be deemed filed for purposes of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any of the Companys filings under the Securities Act of 1933, as amended, unless otherwise expressly stated in such filing.
The Company received an approvable letter from the U.S. Food and Drug Administration regarding its New Drug Application (NDA) for NitroMist(TM) (nitroglycerin lingual aerosol), indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. The Company currently anticipates that it will submit the process validation release data relating to NitroMist(TM) in the first quarter of 2006 and anticipates possible approval of NitroMist(TM) in the second quarter of 2006.
(c) Exhibits.
99.1 | Slide Presentation used at October 26, 2005 CE Unterberg Towbin Emerging Growth LifeSciences Conference. |
99.2 | Press release dated October 19, 2005, titled NovaDel Pharma Inc. to present at CE Unterberg Towbin Emerging Growth LifeSciences Conference. |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
NovaDel Pharma Inc. By: /s/ Jean W. Frydman Name: Jean W. Frydman Title: General Counsel |
Date: October 25, 2005
Exhibit | Description |
99.1 | Slide Presentation used at October 26, 2005 CE Unterberg Towbin Emerging Growth LifeSciences Conference. |
99.2 | Press release dated October 19, 2005, titled NovaDel Pharma Inc. to present at CE Unterberg Towbin Emerging Growth LifeSciences Conference. |