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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: russet who wrote (8517)	1/27/2002 12:12:49 AM
From: axial	Read Replies (1) \| Respond to of 14101

Russet - "Are we overestimating the market for Pennsaid?" That was your question, not mine. I was merely repeating it, as a representative question from "the market". If you go back on this thread (I don't know if you're an investor, a short, or what) you will find graphs, with percentage sales projections, from other posters. All the info which you purport to "know" is there, in plain sight. The questions about the UK have been answered a thousand times (differences in the market, differences in marketing, different rates of uptake). As DMX itself has said, we are now entering the stage where presciptions will be renewed; we can expect an upturn each year. A search on this forum will answer most, if not all your questions. The purpose of my post was to point out that the time is rapidly approaching when answers from posters will not suffice, logical and reasonable though they may be. The time is approaching when results will have to speak. As to your other points, a little bit of DD will find all your questions answered. "...I was here too listening". Au contraire, mon ami, you appear not to have read any of the posts that have dealt with your questions in considerable detail. "But if the drug can't make it in the UK in a short time,...why should anywhere else be any different? When does that patent run out? Good news travels by airplane, bad news by mule train,...how long has that marketing experiment been going on in the UK anyway' Do you have any idea what you're talking about? On what basis do you conclude that the drug "...can't make it in the UK"? The uptake is slow; it is expected to be slow. Its slowness is understandable. We're not selling Viagra, here. Have you read any of the posts dealing with the differences between the UK and North America? Explaining how the UK medical community adopts new drugs? Either you're too lazy to perform a little DD, or you're doing a little back-door bashing. Regards, Jim

To: russet who wrote (8517)	1/27/2002 3:02:03 AM
From: Montana Wildhack	Respond to of 14101

Hi Russett, The world doesn't work that way much to our detriment. Actions are as often ego gratification or random as they are goal driven or accepted process. Thus the EU's adherence to the MRA for drugs and Health Canada's phase 3 - phase 4 - phase 3 - black hole shuffle. The best example may be the Acqua deal. The verbage of the agreement (and holding period) versus the actual mechanics (as uncovered, documented, and forecast by this board). The big players will be here all too soon. Just as soon as much of the risk is gone. Dimethaid did not enter a relationship giving one of them process control. There are hundreds of companies just like us and when one gets interesting - it gets bought. High risk at $5 doesn't sell in boardrooms the way strong prospects at $15 do. Large investors and drug majors hate to fail even when we're talking the peanuts DMX is. Risk weighted it doesn't cut it. The marketing in the UK is still in bleeding edge stage. That is, early adaptors have tried it and have had some time to judge results. Their experience will be shared through the strong peer relationships. This will be much more effective in europe than uppity patients suggesting their own ideas. Advertising is illegal in the UK. Neither of those situations exist in North America. The wedge should grow steadily for reasons understood here (it works and works well) largely due to the predicted high refill rate. As doctors see results from their own early adaptive patients they will suggest it to less adaptive patients more confidently. In the US it will be TV day one. J&J is interested in Pennsaid as a means to the enourmous NSAID market with a nicely differentiated product. 80 million in sales is not on their minds (1%). Bluntly, that's stupid. In assessing the risk to successful FDA approval I would estimate over 95% is getting approved to be inspected. I think passing the inspection for dummies might be a third visit to re-inspect, and getting the approvable to approved is finally a matter of the FDA decisions on labelling, marketing, etc - like the terms or lump them. I agree with you that I expected more from Europe overall. Still we've learned a lot that should provide experience in future biotech investments (at least for me). We must remember the road we've come down to understand investor sentiment. Lots of delays. Little communication during periods and unmet expectations set by themselves. Not to mention some Bay street feelings. I see 2 possible scenarios: 1. Pass inspection. Get approvable letter. Sign with J&J. Finalize labelling, marketing, advertising words, etc. Launch at some future date. 2. Correct errors and pass reinspection. Get approvable letter. Sign with J&J. Finalize labelling, marketing, advertising words, etc. Launch at some future date. According to my reading inspection is the last 'test'. The following quote posted earlier suggests to me there is a decent chance of passing the first time - but I'm satisfied with either scenario. While passing the FDA inspection is not assured, the Varennes facility did pass an independent EU inspection by an inspector from the UK Medicines Control Agency before approval was received last year in the UK. Ms. Keeler hired independent consultants to audit the plant ahead of the formal inspection and McNeil did a prior inspection as well. An August 16 press release stated the Company was continuing "to recruit technical staff to meet its quality requirements in support of a pre-approval inspection by the U.S. Food and Drug Administration" which may indicate the company was receiving council directly from the FDA on how to ready the plant for inspection. Wolf