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

To: SofaSpud who wrote (13422)	4/20/2004 3:17:17 AM
From: axial	Read Replies (1) \| Respond to of 14101

Spud, I know how you feel about FDA. That hope has been all that's sustained many investors. That, and the hope that we might be able to kick those bums out of management. Way back when, I posted: "Saved, from Canada's saviors, was Dimethaid - by the location of its present and future production facilities in Varennes. No one else could have done it. Without the influence of the Bloc, we would all probably have died, waiting for approval from HC. I wonder if we'll have to build production facilities in the States?" As Captainklutz pointed out, however, HC got the last laugh by giving Pennsaid a "non-approval approval" "That 3 month approval is another major problem I meant to point out. It's actually right in the indications section of the product monograph. It's approved for a 3 month period of use whether continuous or in the aggregate. I've never seen Health Canada force this type of restriction on a drug that is intended for chronic use. It's basically a non-approval approval. Approved for sampling purposes only. Kind of mind boggling that people at Health Canada get paid for pulling this kind of nonsense. Force a company to do a long term phase IV trial before approval but then reject the data because it isn't blinded. Only in Canada. In any event, the limitation is a key reason the formularies won't provide coverage. One of their big concerns in addition to price, is inappropriate usage, off-label for instance. Any use of Pennsaid for more than 3 months is off-label. That's the perfect excuse for the formularies: it's not supposed to be used for more than 3 months so why should coverage extend beyond that. In the best case scenario they might cover it for 3 months. Whether that would provide meaningful coverage for patients who would be forced to pay for it out of pocket after 3 months is debatable." stockhouse.ca The question is: has FDA imposed the same limitations on Pennsaid? Is that what caused the non-appearance of "good news" two Augusts ago? A few of us speculated at that time (using exactly the same phrase: "non-approval approval") that FDA did approve, but that the approval was so limited that it didn't meet the needs of Dimethaid or JnJ. So RK sent it back. But, as Klutz pointed out with HC, that presumably would have required more trials, ergo more cash. Management's estrangement from The Street, and cost-effective financing means that ain't gonna happen. Which means no FDA approval. Well, you never know. FDA approval would be a good thing, regardless of how we feel about the clowns managing the company. Maybe it will happen. My guess is that whatever approval Dimethaid settles for (if any, which I doubt) will be a "non-approval approval" - maybe even worse than HC's. Regards, Jim

To: SofaSpud who wrote (13422)	5/7/2004 8:39:39 AM
From: the Chief	Read Replies (2) \| Respond to of 14101

Of course, the minute my sell order is filled, the stock will be halted to announce approval. But I'm seriously considering it. I think this is where everyones problem is! Some of you have to start to admit that the submission to FDA must be somewhat lacking in substance. The ongoing discussions that Beckie referred to years ago allows her to continue with the spectre of FDA approval. I am absolutely amazed that she has been able to con what I consider to be a rather smart BB. You guys are articulate and thorough but you lack onething in your board character. Suspicion! No one is terribly suspicious that things may not be what they are. No one bothers to actually find out what is going on with FDA. No one demands to have a full accounting of that FDA submission. If I was a useless CEo with no understanding on how to run a Bio company. I would do the following: 1) Milk an FDA submission that has to have 4 inches of dust on it, until I retire to an old age home 2) I would continually spout upside of sales of my "drug" allover the world, quoting cream usage until I was in a froth 3) I would blame everyone else for my incompetence. 4) I would scream from the hilltops that their is a conspiracy preventing me from fullfilling my destiny 5) I would as the miracle drug fails to meet expectations in sales have another wonder drug in waiting 6) I would then buy the company for more money than I could possibly ever hope to see 7) I would give shareholders the deal of the century everytime I could and offer "bargain warrants' 8) I would make sure my husband/wife was benefitiing as much as possible 9) I would alienate every brokerage I could so that no one could really analyze my chances of success 10) I would sign up a hedge fund to fund me to keep me alive 11) I would prevent questions at all AGM's except for those that are complimentary 12) I would keep my shareholders guessing what my next move was. I would admonish any shareholder that questioned my leadership and I would cut off all information that coud be used against me in the future. Who am I?