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

To: TheBusDriver who wrote (12909)	9/17/2003 9:32:48 AM
From: menanna	Read Replies (4) \| Respond to of 14101

Hi Wayne, The deal with Italchimici (see DMX last quarterly report) is for real, and you could get your "go green" wish. Italchimici is a serious private company. It sells a 30ML tube of Pennsaid @ 11,59 Euro. The market for anti arthritic products is huge in Italy. Italchimici's description page for Pennsaid says it all (it is in Italian though. I'll PM translation if you want) ciis.it Buona fortuna Anna

To: TheBusDriver who wrote (12909)	9/18/2003 12:51:02 AM
From: axial	Read Replies (1) \| Respond to of 14101

"Should have bought it, eh?<g>" After all the past false starts, it's hard to overcome the doubt. I wish I'd bought more, but I was already overcommitted. "If we are lucky in 6 months the header is rewritten." Wayne, I think the next 6 months are going to make up for a lot of misery. The only big unknown is the Silent Partner in our investment - the regulatory agencies. But here's the thing: in spite of justifiable doubts about a snag with the FDA over Pennsaid, they have never raised the safety issue. If safety was a primary concern, we would have known it long ago. I believe, more than anything else, it's just a question of time. With WF10, safety is obviously not an issue. No doubt about that. The only real question is efficacy - and there's very little doubt there. It's true, that only ~2% of patients using HAART now progress to AIDS-defining events. From the protocol... "The statistical power of this study is based upon current information regarding survival rates and incidence of AIDS-defining events, which have declined dramatically since the recent introduction of combination antiretroviral drug therapy. In fact, the rate of mortality and clinical progression of HIV disease may continue to decline during the course of the trial. Therefore, the present study is designed to accommodate the possibility that a decrease in frequency of death and AIDS-defining events may reduce statistical power." Predictably, it's also true that less than 1/4 of patients had reached a clinical endpoint by week 48 - or else the trial would not have been extended to 96 weeks. "The study will be terminated and the endpoints will be assessed when the final surviving patient to receive treatment has completed the Week 48 follow-up evaluation. Evaluations after the 48-week time point will be used to assess continued safety and efficacy of WF10. If less than 25% of the total patient population (60 patients) has reached a clinical endpoint (i.e., occurrence of a new AIDS-defining event or death), the study may be extended to the Week 96 follow-up evaluation of the last patient receiving treatment." The Interim Safety Report revealed that some clinical endpoints were being reached. "Results: A total of 193 patients have been randomized at 30 centers with 190 screening failures (54% successful screening rate). Median follow-up period is 10 months. Twenty-two primary clinical endpoints have been approved; most frequent are PCP (8) and crypto meningitis (4). Fifteen deaths have been reported. 83% of the 125 serious adverse events (SAEs) were judged unrelated or remotely related to drug/placebo. Thirty-eight SAEs (30% of total) have been reported as possibly or probably related to the drug/placebo: anemia (4%), neutropenia (3%), phlebitis, pneumonia, or bacterial infection (2% each), muscle pain, pancreatitis, pulmonary edema, dehydration, or seizure (1% each). SAEs included 98 hospitalizations that resulted in a total of over 700 hospital days. As confirmed by the Chairman, the ISMB reviewed all reported serious adverse events and has expressed no safety concerns." The SAEs are interesting - note the terminology "...related to drug/placebo". None of the reported SAE's have been seen in other literature on WF10. It's logical to conclude that almost all the SAE's were related to placebo - anemia, neutropenia, phlebitis, pneumonia, or bacterial infection , muscle pain, pancreatitis, pulmonary edema, dehydration, and seizures. The results of the ISMB review say to me that the conclusion stated above is correct: these adverse events were mostly happening to placebos - not patients on WF10. Because if they were attributable to WF10 - then the ISMB would have had serious concerns. That brings us back to the Vanderbilt phenomenon, posted on in May 2002: the emergence of two distinct populations. The inference is that these two distinct populations had already occurred by the time of the Interim Safety Review. Not proven - but if you know that WF10 rarely causes SAE's (which we do know) - then you have to attribute most of these SAE's to the placebo population, or to patients already too sick to be helped by WF10. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Apologies for the long post. Maybe sometime we can get into surrogate endpoints and the "statistical power" of the P3. The point is, WF10 looks very good. Pennsaid looks very good. And lately, so does DMX. Holding this stock is starting to be fun. Jim