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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 OF THE SECURITIES EXCHANGE ACT OF 1934
FILING NO. 1 FOR THE MONTH OF DECEMBER, 2000
VISIBLE GENETICS INC.
(Exact name of Registrant)
700 BAY STREET, SUITE 1000, TORONTO ON, CANADA M5G 1Z6
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F
Form 20-F |X| Form 40-F |_|
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes |_| No |X|
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VISIBLE GENETICS INC.
On December 14, 2000, we announced that we received comments from the
US Food and Drug Administration ("FDA") on the our submission for our
TRUGENE(TM) HIV-1 Genotyping Kit and OpenGene(TM) DNA sequencing system, that
was filed with the FDA in September of this year.
The FDA letter contained a series of questions related to the
submission. We expect to address the questions promptly and believe that no
additional clinical trials will be necessary prior to receiving permission to
commercially market the product. In addition the FDA provided preliminary
comments on label copy that would be used for the final product.
All of the questions in the FDA's comments relate to issues which we
feel confident can be addressed in a timely fashion. We currently expect to
submit our response to the FDA by the end of January, 2001.
This Form 6-K contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act of
1995. These forward-looking statements are subject to risks, uncertainties and
other factors which may cause our results to differ materially from
expectations. These include risks relating to the ability to obtain regulatory
approval, market acceptance of genotyping and our products, delays in, or the
refusal of, insurance companies and other third-party payors to reimburse us for
our products, delays in product development, delays in making our new Atlanta
manufacturing facility operational, and other risks detailed from time to time
in our SEC filings, including our most recent Annual Report on Form 20-F. These
forward-looking statements speak only as of the date hereof. We disclaim any
intent or obligation to update these forward-looking statements.
We hereby incorporate by reference this Form 6-K into our Registration
Statements on Form F-3, and into the prospectuses contained therein, (File Nos.
333-67607, 333-68939, 333-91155, 333-94649 and 333-40616) and our outstanding
Registration Statements on Form S-8 and into the reoffer prospectuses contained
therein.
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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, thereunto duly authorized.
VISIBLE GENETICS INC.
Date: December 14, 2000 By: /s/ THOMAS J. CLARKE
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Name: Thomas J. Clarke
Title: Chief Financial Officer
