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Biotech / Medical : SCIO Scios Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Robert Cohen who wrote (1378)	5/29/2001 8:42:32 PM
From: Miljenko Zuanic	Respond to of 1477

Tyenol is also around for 50 years. Still, it does not stop hospital to charge 3-5 buck per pill. Miljenko [eom]

To: Robert Cohen who wrote (1378)	5/29/2001 11:37:49 PM
From: Biomaven	Read Replies (1) \| Respond to of 1477

Robert, If the AC had been asked to approve NG based on the SCIO study what would their response have been? Aside from wedge pressure at a single timepoint, I think NG failed to significantly beat placebo on any other measure. This is an interesting quote from the FDA briefing document (not from the SCIO section <g>): Less than 60 µg/min of nitroglycerin led to effects on PCWP that were similar to those of placebo. Yet, the effects of the 0.01-µg/kg/min dose of Natrecor ® on SBP were similar to those observed with less effective doses of nitroglycerin. Therefore, although both Natrecor ® and nitroglycerin are vasodilators, the relative effects of the two agents on PCWP and SBP suggest that the 0.01-µg/kg/min dose of Natrecor ® had a better hemodynamic benefit-to-risk profile. That is, Natrecor ® led to greater preload reduction than nitroglycerin, without a corresponding increased risk for excessive effects on systolic BP. Personally I do not believe this trial (which was by far the largest and most rigorous NG trial ever) conclusively demonstrated that NG was effective. I agree that NG may not be the universal standard of care, but it was what the FDA asked SCIO to compare with Natrecor. Peter