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Biotech / Medical : Regeneron Pharmaceuticals
REGN 726.41+4.9%Dec 10 3:59 PM EST
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To: keokalani'nui who wrote (701)11/2/2002 1:21:17 AM
From: Miljenko Zuanic  Read Replies (1) of 3559
 
WE,

Yes, I think that few percentage point drops in retention rate is due to reaching 12 months time frame from inflexion point during requirement phase (Oct/Nov-2001). There is no rest period (as far as I know) so pts continue with treatment if they elect so. I believe that they will be able to retain about 60-70% of those who will complete 12 months, which is ~45-50% for 24 months (or ~1000 pts). IF this materialize in real word it will be significant positive.

Interesting is that pts and MDs will continue to be blind in regards who was on placebo and who on drug in first 12 months. So, in addition to overall safety data (which is very important for this trial) REGN will actually do another randomized open-label 12 months PIII trial. Two in one. Only this time they will compare additional weight loss at 24 months (or weight loss for those who were flat or even gained weight in first 12 months), placebo relative to those on drug. Severe and morbid obesity is lifetime disease and extended data will be as important as first 12 months.

Also, remember that this pts are diabetes negative at start. REGN will be following laboratory markers for pre-diabetic condition as well as other co-morbid factors. Data will be compared to those from literature. With 1000 pts database they will be able to separate sub-groups to evaluate certain variable.

Miljenko
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