Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : biotech binary events -- Ignore unavailable to you. Want to Upgrade?

To: Robohogs who wrote (251)	4/15/2007 11:32:52 PM
From: kenhott	Read Replies (1) \| Respond to of 295

April 11, 2007 Neurochem's eprodisate (KIACTA™) PDUFA date extended three months by FDA - Neurochem (International) Limited (Neurochem), a wholly owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX: NRM), announces that it received notification from the United States Food and Drug Administration (FDA) that the action date for FDA's review of the New Drug Application (NDA) for eprodisate (KIACTA™) for the treatment of Amyloid A (AA) amyloidosis, has been extended to July 16, 2007. Previously, the action date under the Prescription Drug User Fee Act (PDUFA) for the eprodisate (KIACTA™) NDA was April 16, 2007. The FDA is extending the PDUFA goal date by three months to provide time for a full review of an amendment to the eprodisate (KIACTA™) NDA submitted by Neurochem Inc. in February 2007. This additional submission is considered by the FDA to be a major amendment to the NDA, allowing an extension of the action date. ++++++++++++++++++++++++++++++++++ The ALZ data should be coming up soon. April/May time frame. For everyday option trading, something like Optionsxpress is pretty good. I am short the stock and long some calls. I am not sure the stock is all that shortable at this point. -------------------------------------------------- Sorry Jon, going to save a little cyber space/tree .... <Different reply> I don't know what to say about what you have been reading about DNDN (Yahoo??). I pretty much stay away and for apparently good reasons. I don't have any answers. But for instance I think the view that it should come down to answer A or B or C could be wrong. It is not unusual for the FDA to be talking to the sponsor about aspects of the approval. So they may surprise the market with an unconventional answer. Yes, maybe not likely. My personal believe is that the FDA should approve with a short leash. Something along the line of an informed decision program, outlining the exact issues of the different options for these ill patients. And only specific "patient sets" with signed consents after going thru the program should be allowed to get treatment. And of course requiring the results of the on going trial. When you and I post on a board about this disease or that disease it is all less than real. But these patients have guns to their heads and there should be a place for Provenge at this point (or whatever the heck it is named). I came to my conclusion looking at the data. For me, it was like a rubik's cube. As I turned it looking at different aspects of why the survival data should or shouldn't be right, I found that the colors were falling into place. No, not a perfect cube, but too many reds, and blues, etc. in the right place. And I looked at the cube and thought to myself...... how likely is this all luck? People with a scientific viewpoint dislike DNDN for good reasons. Too many technical reasons why it could all just be poo. But I looked at the cube and for this difficult group of patients, thought it make sense to approve. The way to make money in this stock may well be between now and May 15th. Fear and greed should provide a chance to profit as the stock goes up and down.