PROLONGATION OF THE FDA APPROVAL PROCEDURE FOR BIOHIT'S GASTROPANEL TESTS
BIOHIT OYJ STOCK EXCHANGE RELEASE ON 7 MAY 2008 AT 09:50 AM
PROLONGATION OF THE FDA APPROVAL PROCEDURE FOR BIOHIT'S GASTROPANEL TESTS
The US Food and Drug Administration (FDA) has demanded further clarifications
regarding the clearance application for the Pepsinogen I and II tests included
in the GastroPanel examination. Authorisation was previously expected before the
end of the first half of 2008 but due to the new request the procedure will be
prolonged. At this stage it is therefore difficult to estimate the schedule for
the whole approval procedure.
We will inform about the case later, as we get further information from FDA.
Osmo Suovaniemi
President & CEO
Biohit Oyj
Further information:
Osmo Suovaniemi, M.D., Ph.D., Professor
President & CEO
Tel: +358-9-773 861
GSM: +358-40-745 5605
Email: osmo.suovaniemi@biohit.com
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