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.

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

To: DaveAu who wrote (11298)	10/26/2002 7:38:14 PM
From: axial	Respond to of 14101

Hi, Dave - "She was also clear that these were for marketing and haven't been shown to the regulator because that would just slow down the process as they were reviewed." Thanks for that: it makes sense, and it establishes that the process is apart and separate from the approval process (Director Review), which goes on, unimpeded. I append some comments by CaptainKlutz on the question of the possible purpose of these studies: "I think it is more likely that any head-to-head comparisons that DMX is presently conducting are largely for the purposes of reimbursement -- convincing third party payors to list Pennsaid on their respective formularies -- and to some extent, pricing,. It is highly unlikely that the FDA would permit a superior safety claim for a new drug on the basis of short term (12 wk.) trial data. I expect you would need several years experience with the drug and a number of long term pivotal trials before it would be allowed. On the other hand, the drug payors are quite willing to rely on short term comparative data in deciding whether or not to list a particular product. In fact most of them will insist on it and it will be to the company's advantage to have some economic outcomes data before they seek a listing with the various payors. The current studies are likely aimed at the provinces and the HMO's. (And possibly the regulatory agencies in Germany and France where, if I am not mistaken, the approval of the drug depends on the willingness to pay for it in the first place.)" stockhouse.ca ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I think the question of whether or not these studies would be acceptable to the FDA in terms of changes to labelling/marketing is unresolved, and is worthy of further research. He may be correct, I don't know. However, Klutz rightly brings up the importance of pricing in different jurisdictions, and trying to address the issue of cost-effectiveness. It is known that the price of Pennsaid is high, relative to other topicals. However, the posts of murray6, and available data establishes the reality of polypharmacy in many older patients. It is also a well-established fact that the most expensive treatment costs are incurred at the time of intensive care, when patients are in near-death condition. The link between COX2's, and putting patients into that expensive and ruinous condition has not been made - but many physicians are starting to raise questions, and the possibility has to be considered. If that link can be established, then the use of Pennsaid, despite its price, may turn out to be the right decision: prolonging (not decreasing) mortality, and decreasing managed-care costs. If statisitics even suggest that possibility, then the use of COX2's may turn out to be simply inhumane, never mind cost-effective. I'm speaking here of studies where data suggests a linkage, such as smoking studies, which did not prove a direct causal link to lung cancer. The case for cost-effectiveness is one that DMX has to make. Jim

To: DaveAu who wrote (11298)	10/27/2002 12:23:02 PM
From: Montana Wildhack	Respond to of 14101

Dave, Thanks. I did hear about the end September date but did not hear the comment about slowing the down the process. This does leave the question open where she publicly now stated the submission was done but that they are in some US labelling discussions. It may be some point or points of clarification then unrelated to those marketing studies (there were at least two one for Celbrex and one for Vioxx, one in Montreal and one in Vancouver). This does give us a decent window into where we are overall regardless of the role of those studies. While I think we should be trying to piece the picture together as best we can as part of our effort in staying as close to the events as possible its highly probable that whatever those current labelling discussions are about - they will be cleared up and resolved to pave the way for approval. It seems unlikely to me in the extreme that at this point a review of the entire submission which had the mark of a rejection on it (already very unlikely) would then take time discussing labelling aspects first. I believe the overall experience of this stock has been dominated by the comments that management has made over the years based on optimism and expectation that have not panned out and created an overall impression of inability. I chose to view these issues generally as inexperience although Provalis was clearly inability. The point is that this experience combined with the sheer size of the odds against approval at earlier dates and the constant negatives of no cash and disappointing sales from Dioptic and the UK - have created that long term downward trend line that frankly is deserved at this time. Just as true I believe is that the size of a payoff on US approval of Pennsaid would be huge. This becomes very clear when you assess the market size and growth combined with the current competition's challenges about safety. I believe we'll get a chance to assess all this since even though its apparent there is no verdict in the mail, in my opinion it is also true the odds of a rejection at this point are near zero. Wolf