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Biotech / Medical : ARADIGM CORP. ARDM

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To: rkrw who wrote (196)	4/30/2004 1:03:11 PM
From: keokalani'nui	Read Replies (2) of 255

Having listened to novo's and ardm's cc: 1. Both companies believe it is not the device, nor is it membrane-permeability related. 2. The 'present consensus' is that the antibodies are not neutralizing. 3. The antibody formation is significant and it will be a primary focus of the coming analysis. 4. There is precedence in early insulin replacement studies (80s) that antibodies, though not neutralizing, can over the course of a study have a modifying effect on insulin. So they will be studing samples for the insulin profiles and whether there is progression of this unfavorable BG outcome. I believe this is the first suspect. 5. Could be that this is limited to T1, as they have susbstantially more circulating abs at baseline. However, the T2 study originally planned to start this year will be delayed until they figure this out. 6. Novo says in the August cc they ought to have an answer. 7. No one knows if exubera has the same issue, as no daytime bg data has been released. 8. This was all very unexpected. A good question is how long was the T1 P2? EDIT: sold the hot shares for a .04 loss.

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