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  • DIAMYD MEDICAL ANNOUNCES FIRST MEETING WITH FDA TO DISCUSS TYPE 1 DIABETES CLINICAL PROGRAM IN THE US

DIAMYD MEDICAL ANNOUNCES FIRST MEETING WITH FDA TO DISCUSS TYPE 1 DIABETES CLINICAL PROGRAM IN THE US

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Press Release, Stockholm, Sweden – December 15, 2006 – Diamyd Medical AB
(SWEDEN NOMX: DIAM B; US ADR: DMYDY)

Diamyd Medical announced today that it is submitting a Pre-IND/ End of Phase II Briefing Package with the United States Food and Drug Administration relating to a proposed type 1 diabetes clinical trial in the US. The Briefing Package is submitted in support of a meeting with the agency scheduled for January 29, 2007 in Washington DC. Both the Briefing Package and the Pre-IND/End of Phase II Meeting are important first steps in the process for seeking approval to conduct clinical studies in the US.

“We look forward to opening the dialog with the FDA regarding the potential initiation of our clinical program for Diamyd® in the US” stated Anders Essen-Möller, CEO of Diamyd Medical. “We obviously cannot predict the outcome of any meeting with the regulatory authorities, but we hope we will gain some valuable guidance towards structuring a suitable US clinical program for the continued development of Diamyd® as a therapy for type 1 diabetes.”

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