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

To: Icebrg who wrote (13349)	10/6/2004 2:51:47 PM
From: Sam Citron	Respond to of 52153

Erik, Thanks much for your thoughtful reply to each of the points I raised. Your explanation makes a lot of sense. The only thing I do not understand is why a person who wants to "mak[e] sure there is something left after returning home from a three months bike tour" is "not into options at all" as there are many potential hedge strategies available to option traders, such as the reduction of the very risk that you cited. Sam [who would love nothing more than to take that bike tour with my recumbent which is so effortless to ride, but it will have to wait for my son to move out of the diaper stage first]

To: Icebrg who wrote (13349)	10/6/2004 4:45:17 PM
From: bio_kruncher	Respond to of 52153

>>What exactly does it mean that "[t]he sought endpoint is a 30 percent improvement in median survival time." Does this imply that the FDA approves IFF they reach this precise endpoint?>> >> Why 30% median, instead of, say, 25% mean? >> The 30% improvement is not required for approval. I have heard repeatedly from FDA that there is no minimum effect size on survival that needs to be shown for survival studies. A certain effect size (30% here) has to be assumed in order to plan the number of patients and power of the study. A statistically significant difference in survival would be what is necessary to show substantial evidence of efficacy. While the median survival is often used to summarize results in survival studies it is really only weakly related to the statistical tests for differences. The median difference only indicates the horizontal distance between 2 survival curves at the 50% survival point(on y axis) while the statistical tests essentially incorporate the vertical distances between the curves across the the whole curve.