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Biotech / Medical : CLTR COULTER PHARMACEUTICAL

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To: Gordon James who wrote (508)	2/2/2000 1:30:00 PM
From: Vector1	Read Replies (1) of 666

Gordon, Biowa, Peter et al, Additional bad news for IDPH. They are going to be delayed in their BLA as well. From todays press release. (Snip) Due to process and equipment changes that have been implemented in the manufacturing scale-up and switch over from Rituxan, the ZEVALIN manufacturing campaign has been extended by approximately three months. Also, within this time frame, we are preparing to submit with our isotope supplier a New Drug Application (NDA) for yttrium-90 from a new and larger site that has the capacity to support global commercialization of ZEVALIN. As a result, IDEC currently anticipates submitting the BLA for ZEVALIN and the corresponding NDA for yttrium-90 during the fourth quarter of 2000.

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