North American Vaccine Message Board

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Biotech / Medical : North American Vaccine

NVX 0.985

-5.3%

Jan 30 9:30 AM EST

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To: Don W Stone who wrote (197)	1/9/1998 3:49:00 PM
From: Paul Lee	Read Replies (2) of 507

another step closer North American Vaccine Advised by FDA that CERTIVA(TM) is on Track for Completing Final Steps for Licensure BELTSVILLE, Md., Jan. 9 /PRNewswire/ -- North American Vaccine (Amex: NVX) announced today that it has been advised by the U.S. Food and Drug Administration (FDA) that CERTIVA(TM) is on track for completing the final steps for licensure. CERTIVA(TM) is the Company's investigational vaccine against diphtheria, tetanus, and pertussis disease. This information was conveyed to the Company at a meeting held with FDA officials this week. At that meeting the FDA expressed its objective of promptly completing the review process for CERTIVA(TM). Towards this end, the FDA has requested additional information which the Company intends to submit shortly. Based on its meeting with the FDA, the Company anticipates that the regulatory review process could be completed during the first quarter of 1998 or shortly thereafter. This is a forward-looking statement and the factors which may affect its outcome include the ability of the Company to timely provide the information it intends to submit, the acceptability of the information being submitted, the time it takes for the FDA to complete its review process and the acceptability of the Company's applications in their entirety, among other factors. There can be no assurances given as to the final FDA determinations or that CERTIVA(TM) will receive regulatory approval in the anticipated timeline. The regulatory review of a vaccine product is an ongoing, interactive process. Accordingly, the Company does not intend to continuously issue periodic updates until CERTIVA(TM) completes its regulatory review.

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