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Replies to #1756 on Biotech Values
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DewDiligence

04/11/04 4:00 AM

#1758 RE: AlohaDan #1756

Re: GTCB:

>> The only other fly I see in the potential use of transgenic protiens [and I profess no knowledge in this department] is that at some time in the future they would be able to construct equivalent complex proteins artifically. But given why they are trying to produce them transgenically I see that that threat is as least 5 years out if not more. <<

Five years strikes me as way too soon for synthetic construction of the kinds of complex proteins we are talking about. If I had to guess, I’d say that such technology is at least 20 years away, if it can be done at all.

>> So how long will it take the euros to act on ATryn® ?
1Q05? <<


1Q05 is the company’s (perhaps conservative) guidance for actual EMEA approval. This assumes that the Committee for Proprietary Medicinal Products (CPMP) recommends approval during 4Q04, as it normally takes a few months for EMEA to rubber-stamp a CPMP recommendation.

>> Am I right that that would be the next big event for the company? <<

The CPMP recommendation (not the actual EMEA approval) will be the biggest news, but other market-moving events could come sooner. The two obvious candidates for consequential news are a new partnership and a break in the deadlock between GTCB and the FDA over the design and indication for a U.S. ATryn trial.