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Biotech / Medical : IMNR - Immune Response -- Ignore unavailable to you. Want to Upgrade?

To: margie who wrote (1357)	5/17/1999 4:24:00 PM
From: jake burns	Read Replies (1) \| Respond to of 1510

Good News: Remune significantly lowers viral load. Bad News: More time is needed to gather data to support an NDA for usa registration. A trial will commence in 1Q 2000 which will last 48 weeks. Worst case scenario: Remune will be approved in mid 2001. In the meantime, WLA/Agph/IMNR will discuss with the FDA the possibility of using the 250 patients from the ph3 along with the spanish trial data to support an earlier application (about 12 months from now). So best case is the drug is approved in 4Q 2000. Other comments from the conference call: thai application should be by August's end; approval could follow within 90 days of application (Year end 99). RA deal by year end. European approval of Remune by mid 2000. The press release today emphasized that the deal with Gallo was non-binding. I wonder what will happen on that front.