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DewDiligence

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DewDiligence

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Re: Praveen post# 18459

Saturday, 11/19/2005 9:39:39 PM

Saturday, November 19, 2005 9:39:39 PM

Post# of 257295
Praveen et al re KERX data:

I finally listened to the CC from last week and I’m no more impressed than I was before listening. In fact, I’m somewhat less impressed now.

One reason is that I’m suspicious of companies who change their story ex post facto about what kinds of results are good results.

Perhaps the main question about the most recent data is the lack of a standard dose response: the 400mg cohort had substantially worse results than the 200mg cohort. On the recent CC, Weiss called this a “bell shaped dose-response curve” and said that this bell-shaped curve was expected given KRX-101’s MoA, which includes both an agonist and an antagonist.

I found Weiss’ assertion surprising, so I went back and checked what KERX was saying about this subject before the recent data came out. Here’s an excerpt from KERX’s PR on 6/29/05 (#msg-6895846):

>>
A randomized, double- blind, placebo-controlled, Phase 2 study of the use of sulodexide for treatment of diabetic nephropathy was conducted in 223 patients in Europe, and was published in the June 2002 issue of the Journal of the American Society of Nephrology. The results of this [earlier] Phase 2 study showed a dose-dependent reduction in proteinuria or urinary albumin excretion rates.
<<

No mention about any “bell shaped” curve in the post-mortem of this earlier phase-2 study.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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