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

To: betthepharm who wrote (330)	3/31/1998 6:50:00 PM
From: John McCarthy	Read Replies (1) \| Respond to of 1510

B - If we're just trying to get to bat with the ADVISORY panel by May, are we looking at another 6 months before we go up against the FDA panel? This wouldn't product out the door till Q199. Regards, John McCarthy

To: betthepharm who wrote (330)	4/2/1998 10:36:00 AM
From: Easy Mark	Read Replies (1) \| Respond to of 1510

Early approval of Remune requires a showing of therapudic gain. Since Remune does not directly kill the virus, the results of the data analysis in May 98 (to be released June 98) will probably not show Remune to be better than triple drug therapy when measured over a one year clinical trial. But, an interesting point was made in IRC's 10k this week. Only 20-30% of aids patients use triple drug therapy, largely due to the side effects. For patients who cannot tolerate those drugs, Remune could be a therapudic gain. If the data support the phase II results, I could see a reasonable response by FDA being a limited approval for use when triple drugs are not appropriate. That still leaves open the opportunity for broader usage approvals at the completion of Phase III or at the completion of the Phase II trial in combination with AZT. This scenario would permit IRC to generate revenue this year, and likely avoid the need for an unfavorable round of financing. They could even keep and develop the RA technology themselves on that scenario. I'd be interested in any responses from medical personnel on this scenario. I find it interesting because many drugs in fact start with highly constrained limited approvals and then the uses are expanded as data is accumulated.