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Replies to #14280 on Biotech Values
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DewDiligence

08/11/05 10:47 AM

#14287 RE: rph_in_wi #14280

Re: GTCB / ATryn launch

>>After looking through the last PR, I still am not sure if this is a consistant statement. I seem to remember an earlier estimate. Anyone know if this timeline has slipped as of this PR?<<

I don’t think there has been any material slip. On today’s CC, the expectation was still for a formal EU approval around the end of 2005. It ordinarily takes 2-3 months for the EU Commission to adopt a recommendation by the EMEA; hence, if the EMEA gives a positive opinion in late October, a formal approval for marketing would presumably come in December or January.