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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Vector1 who wrote (5780)	10/22/1998 2:50:00 AM
From: Andrew H	Respond to of 9719

Hi V1 and all. I was reading GZTC's latest release and cam across this passage: "Upon commercialization of the antibody, Genzyme Transgenics will manufacture bulk product for sale in a market currently estimated to approach $600 million annually worldwide. Genzyme Transgenics will receive manufacturing fees and an undisclosed royalty on sales, resulting in potential revenues of about $35 million annually. The antibody is projected to enter phase III human clinical trials during 1999." Does this mean the FDA will let GZTC manufacture and sell a transgenically produced antibody when actual trials have been done with a non-transgenic version of the antibody? Wouldn't the FDA require all three testing phases to be done with the transgenically produced version? If not, then why would GZTC need to do 3 trial phases for AT111? BTW, congrats to the VD team for managing to keep losses to a minimum in this nasty market!!