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Biotech / Medical : Alliance Pharmaceutical -- Ignore unavailable to you. Want to Upgrade?

To: RCMac who wrote (490)	8/9/2000 1:02:44 PM
From: StockDoc	Respond to of 548

Thanks RCMac, you've been very helpful. I didn't know that the ALLP product needed oxygen tent. Special equipment under special circumstances do not seem to be a serious road-block to me, we've been using all kind of stuff and constantly changing the OR, ICU and ER set up. I new gadget every 3 months is about the average. We love those because they give the impression of constant improvement and advance (real or imaginary). One more gadget is in fact a business opportunity I didn't think of. Who makes those tents? Will ALLP co-market oxygen tents? (I'd advise them to do so.) The competitors, i.e., natural (purified) or recombinant hemoglobins or their derivatives are interesting stuff and the idea of using hemoglobin solution has been around since the late 19th century. I wonder why it is still not on the market after 100 years of research. Is it safety or efficacy or lack of market? I probably should look into data. One is for sure; massive osmotic hemolysis, when red blood cells break and release hemoglobin, is definitely toxic without a single exception, and can be fatal. I'm not sure whether it is due to hemoglobin or cell membrane debris. The data are probably there. The companies you mentioned probably claim total safety but I wonder where the products are? The FDA link has been very useful. I think companies screwed up a bit by chatting too much with the FDA. Discussions with the FDA during product development can be detrimental and kill innovation - as FDA is conservative and their reps , not the top of the MD crop, enjoy putting their personal stamps on projects as achievements. Their roles often go beyond watching out for safety and efficacy. The job of these blood substitute companies should be to prospectively demonstrate statistically significant survival or health outcome (e.g., infection) benefit in a single Phase III study. Where is this study? It would be so easy to do one and should take only a couple of years to complete. Once it is there, all discussions, self-inflicted regulatory wounds and crazy FDA rules become instantly obsolete. In contrast, if blood substitute companies don't think hard enough and go for less relevant endpoints, they open up cans of worms with the FDA and other reg. agencies.