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Biotech / Medical : Acorda Therapeutics Inc.
ACOR 0.880-13.8%Apr 10 5:00 PM EST
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From: kenhott10/13/2009 9:52:32 AM
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Thanks AR and IJ for you inputs. The power of the group can not be under estimated. I have tried to be more than fair re: the FDA position. But if I were less generous, I could say that the FDA has little idea about what to do with this walking issue and endpoints. For instance like CGI (Clinical Global Impression), the FDA doesn't like it because it can be biased. No kidding, impressions can be biased. Wow. And they want a hard endpoint for this treatment like improvement in EDSS which is asking for a disease modifying drug. Good luck with that.

And even thought we all know that seizure is an issue with this drug, by reading the FDA paper you would think it is like a 10% problem. It was 3 seizure out of 1500 patients in the phase 2 and 3 trials in MS and SCI. That is .2%. Out of the 3 seizures, 2 were at the 20mg BID dose vs. only 1 at the intended dose of 10mg BID.

You would think somebody would think... ummm.. this is the way science SHOULD work. Come up with a solution that gives you a good part of the positive effect of the drug while lowering the negative effect of the drug. Instead of saying well it ain't zero so who knows if your drug is REALLY doing anything bad without N=10,000 and duration = 5 years.

I never gamble and I think I am pretty well protected because my net price is ~$7 per share for the Adv. Mtg from trading the stock this last 3-5 days. While the U.S. is the main value driver and it will definitely hurt if they get bombed by the FDA, the ROW will give support to the downside of ACOR.
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