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Biotech / Medical : Acorda Therapeutics Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (24)	4/2/2009 7:53:34 AM
From: kenhott	Read Replies (1) \| Respond to of 120

I see my previous post was, as usual, up to my personal high standards. A new definition for concise BS. :) I'm traveling and having trouble. Need to go back to a rotary dial. I had a major position in the stock and I was very disappointed to see the Refuse To File for ACOR. I listened to the conf call and didn't feel any better. The FDA does not give out RTFs lightly and without good reasons. I suspect that this RTF from the FDA had within it good amount of specific details re: the reasons for the RTF. I didn't like mgt's position during the call, acting like they only had a minimum of details. The RTF name is a little bit misleading. Sounds pretty unimportant. The idea of the RTF is to stop any half-ass submissions from getting thru and using up limited FDA resources. I think it mostly breakdown into two parts. On the one side, the company may have made a total mess of the submission re: formatting, links, forms, etc., to the point that the FDA can't do their job. On the other side, something much more serious, the submitted package, for whatever reasons, has the FDA thinking it is not going to make it because it is missing something important. In ACOR's case, I don't see how it could be just a problem with putting the package together. They are too well funded to make that big of a mess that way. Minor problems with formatting, etc. will be get a RTF. So it has to be the other side. I am sure the RTF they received did have some formatting stuff on it, but that is the filler not the meat. I know they have SPAs with the FDA. Here is the FDA link: fda.gov Until mgt gives more details, No one knows what is missing. Mgt pointed to the fed/fast human study so that I guess is the starting point. But that doesn't make sense to me because they must have provided the supporting details to what would be a standard study. What is wrong with the fed/fast? The best possible outcome is that mgt did something boneheaded like not submitting some available data and/or just made a mess of the submission. The middle ground is maybe they screwed up and have to redo the fed/fast study. The bad possible outcome is something more serious in the RTF.