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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Thomas M. who wrote (6665)	5/27/1999 9:07:00 PM
From: biowa	Read Replies (2) \| Respond to of 9719

Thomas M. >> SEPR released data from three pivotal Phase II/III studies of norastemizole: In a 656-patient environmental exposure unit trial, patients given 30 or 90 mg norastemizole had a significant reduction in symptoms versus placebo or 10 mg of Schering-Plough's Claritin loratadine (p<0.05 for both).<< In a controlled setting, nori did better than Claritin. >>In a 459-patient seasonal allergic rhinitis (SAR) study, both norastemizole and loratadine produced a significant reduction in symptom score 24 hours after dosing following 1 week of treatment (p<0.05). However after the second week neither compound produced a significant reduction due to a high placebo response.<< In the field, they demonstrated equivalence (were they trying to demonstrate greater efficacy, as in the study above?). Oops, by the way, that old placebo effect wiped out the results from the second week. >>In a second, 686-patient SAR study, both norastemizole and loratadine produced a significant reduction in symptom score 24 hours after dosing following both 1 week and 2 weeks of treatment (p<0.05).< Once again equivalence in the field. >>Norastemizole was well tolerated, with no change in cardiac function versus placebo and a small increase in sedation (3.5 percent versus 2.8 percent for loratadine and 1.9 percent for placebo).<< Not clear if that is a statistically significant difference in sedation. IMHO this is not a clear winner. To see SEPR ICE's as other than patent extension plays, they need to demonstrate significant efficacy or safety advantages. Otherwise, would you as a consumer (or HMO) pay a premium for marginally better performance. I think that there are compounds where the SEPR approach will work, not sure if nori is one of them. What do you think? biowa