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Biotech / Medical : Immunomedics (IMMU) -- Ignore unavailable to you. Want to Upgrade?

To: mhubs who wrote (290)	12/18/2004 1:58:19 PM
From: idahoranch1	Read Replies (2) \| Respond to of 371

Hi mhubs, good to hear from you, it's been a while. I agree with you that the company seems focused on getting CD22 front and center with autoimmune. It is a much better indication than NHL as far as getting approval. The reasons for that include. 1. Lupus is unmet need, they treat the symptoms, not the disease. 2. You only have to show safety and efficacy to get approval, with a disease considered fatal like cancer, you have to show the drug is better than the standard of care. So what we have to do is design the registration trial properly, with a significant number of patients, probably 300 to 400. Do it double blind, placebo controlled. If the 14 patients treated in Germany are any indication, the trial should go well. The question is, does the 14 patient data convince a potential partner. It seems to have convinced the FDA to the degree that they are considering a pivotal trial. They have also generated data for Sjogrens that should be released sometime in early 2005, I imagine they have enough data now to add to the lupus data to show a partner if in fact the Sjogrens data is compelling. They were going to treat about 15 patients in that indication as well. I think they are on the right track, however, there isn't enough fuel and the question is, will the perceived value of the cargo compel someone to step up and provide the fuel, and if so, how much.