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Biotech / Medical : Pharmos (PARS) -- Ignore unavailable to you. Want to Upgrade?

To: schadenfreude who wrote (922)	10/11/1999 4:46:00 PM
From: Cacaito	Read Replies (1) \| Respond to of 1386

Mortality decrease was good: down 28%, problem is the low number of subjects. They expected 20% for placebo group, as commonly seen in many trials the placebo group did so well (about 13%)that one could market the placebo! They still showed the dexanabinol group at about 10% to 11%, How could we explain this? Always have into account the benefit of a quality trial in the placebo group. The quality of care tends to be high, and placebo expectations do not match to what is found in trial. The placebo patients get the best quality care and they do much better than expected. One could say that the compound was good enough not to kill people, and still showed some benefits, and beneficial trends, and survived the high placebo quality care. Is the 250 to 300 subjects large enough? yes. For approval, short term and medium term safety has being demonstrated positively safe. FDA will not stop this type of product. Long term safety will be known when dexanabinol is on the market. It is not addictive. There is no magic with 1000 subjects, only about 500 will get the drug, the rest placebo. Problems, of 1 in 1000 are easy to find when a drug hit market, even 1 in 10,000 are easy to pick post marketing. FDA is worry, not paralyzed. It took about a year and a half for Rezulin to find their 1 in 50,000 to 100,000 hepatitis, and liver failure death is even much less and was determined. Is Rezulin going to withdrawn? NO. What about Viagra, clearly killing left and right, NO. And this are too very different drugs, one for a real disease, the other recreational. Forget worries of side effects since dexanabinol has proven quite safe, very safe indeed. Anyway the parent compounds has being used for centuries (maybe millennia) and tens of millions of people. Cannabinoids are very well known (maryhuana,hashish,hemp), take away the harmful fumes and most of the bad effects are gone (some fumes are good too). Even the long term use of Marinol, legal cannabinoid for nausea and lack of appetite for cancer chemotherapy patients, is well known to be quite less than the fumes. Most of the side effects are not worth one's brain. Only for disorders that required long term repeat use, like multiple sclerois, addittional will be necessary, by them it will be out already. EFFICACY is the subject to be decided upon. The difference between a $1.5 and $15 (or much more) share price is efficacy. Dilution is a fact of life and it will happen. Pharmos indicated they have the means for a $5 to $6 millions trial. Another 10,000,000 shares will not kill the stock, and if someone put that much money could be a sign of confidence or not. The 250 to 300 subjects is enough to show efficacy in all the goals, but mortality where it could or could not. If the pII trend repeat itself the higher 800 to 900 number will needed. I have not get into detail calculations. The international and multicener nature of trial will decrease chances that placebo do as good as pII. I expect a lesser placebo benefit (like 15% to 16%). If dexanabinol holds at the 10% to 11%, the data could be there for statistical significance (rough numbers, I will have to check later). Icahn MUST pay at least what we pay. Allergy season is coming, Alrex should do better. Other deals, like rights to Lotemax and/or Alrex in non yet licensed countries (Japan always come to my mind) could bring the money in. xoma is an still developing story, bpi could still be of value. I prefer Aviv and PARS very straight deals with information for shareholders, than those "the FDA gag me xomas". My guess is that this time Aviv is looking for investors to pay $4 to $5 a share.