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Post# of 253276
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Re: DewDiligence post# 47824

Friday, 06/01/2007 11:08:44 AM

Friday, June 01, 2007 11:08:44 AM

Post# of 253276
Paion CC-post-mortem

utter denial by management. Nothing wrong with the drug—the only problem was that those placebos were too darn effective.

To add a little color to DEW's impression, one of the speakers on the Paion CC today said, Desmetoplase did not fail....but placebo by chance had a very good outcome".

I sympathize with the company in that I don't know what they could have done differently. The study was reportedly powered with enough patients, assuming 20 % placebo efficacy. Then, the data reportedly showed a 50% placebo response rate. Who's to blame for that? Keep in mind also that this was before the Cerovive failure---in that study placebo also did better than expected with about 35% efficacy.

So, even though desmetoplase is probably a better drug than TPA, we are left with TPA, the "standard of care", which only 1-2% of stroke patients receive---for very good reasons having to do with a very narrow therapeutic time window and a highly questionable risk/benefit equation even under ideal circumstances.

Fortunately, no position in FRX or Paion.

Urche
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