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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 20, 2000
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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<S> <C> <C>
NEW JERSEY 0-19777 22-3103129
(State or other (IRS Employer
jurisdiction of (Commission Identification
incorporation) File Number) Number)
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25 UPTON DRIVE
WILMINGTON, MASSACHUSETTS 01887
(Address of principal executive offices, including ZIP code)
(978) 657-7500
(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS.
The Registrant, DUSA Pharmaceuticals, Inc., ("DUSA") reports that it
has received an "approvable" letter from the U.S. Food and Drug Administration
("FDA") regarding the commercial version of its BLU-U(TM) brand light source.
DUSA believes that the final approval of the commercial version of its BLU-U(TM)
brand light source is expected at any time. The "approvable" letter stated that
final approval was dependent upon the FDA finding that DUSA's facilities and
those of its' manufacturers, meet all current Good Manufacturing Practices. As
previously announced, the FDA completed its inspections of these manufacturing
facilities in August and has reported no deficiencies to DUSA.
Except for historical information, this report, including the exhibit,
contains certain forward- looking statements that involve known and unknown risk
and uncertainties, which may cause actual results to differ materially from any
future results, performance or achievements expressed or implied by the
statements made. These forward-looking statements relate to the timing of the
regulatory approval by the FDA of the PMA Supplement, timing of the introduction
of the LEVULAN(R) PDT system and commencement of sales. Such risks and
uncertainties include, but are not limited to, final regulatory approval of the
commercial version of the BLU-U(TM), dependence upon third party manufacturers
of the Kerastick(R) and the BLU-U(TM), the timing of the launch of the
LEVULAN(R) PDT system and ability to develop a market for the products and other
risks identified in DUSA's SEC filings from time to time.
ITEM 7. FINANCIAL STATEMENTS AND OTHER EXHIBITS.
(c) Exhibits.
[99] Press Release dated September 20, 2000.
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SIGNATURES
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.
DUSA PHARMACEUTICALS, INC.
Dated: September 20, 2000 By: /s/ D. Geoffrey Shulman
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D. Geoffrey Shulman, MD, FRCPC
President, Chief Executive Officer,
and Chief Financial Officer
