Dendreon Corporation
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zzzster< I VERY STRONGLY believe that a surv adv of only 22% will lessen our chances of eventual FDA approval relative to a significantly higher surv adv %
22% surv adv = 85-90% chance of FDA approval25% surv adv = 90-95% chance of FDA approval 30%+ surv adv = 95-97% chnace of FDA approval>
Weird set of probabilities. Where did you get them from?
From a data-centric point of view (ie, excluding manufacturing concerns), the FDA cares foremost about statistical significance. That means the p value has to meet a threshold. Why? Because the p value bounds the chance of the benefit seen by the drug is a fluke. That's what they care about. They want to be sure that they approve an actual drug, not a sugar pill or water as treatments.
So, let's look at a few statistics on the Survival Advantage, SV:
SV >= 22%: pvalue is guaranteed to be <= 0.043 and with 90% certainty, <= 0.031.
SV >= 23%: pvalue is guaranteed to be <= 0.032 and with 90% certainty, <= 0.025.
SV >= 24%: pvalue is guaranteed to be <= 0.028 and with 90% certainty, <= 0.019.
SV >= 25%: pvalue is guaranteed to be <= 0.021 and with 90% certainty, <= 0.014.
and
SV >= 30%: pvalue is guaranteed to be <= 0.003.
Since we believe that the required alpha is 0.043, as far as I am concerned, if the pvalue goes to a vicinity of 0.03, that is far more than being unambiguous. A SV of 23% would guarantee that and even at 22%, there is a 90% chance of the pvalue <= 0.031.
Reaching 24% would be delightful. But, there is no need to hype for anything higher than 22-23%, especially something like a 30% where the pvalue would be an out of this world 0.003 or less.
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| Msg # | Subject | Author | Recs | Date Posted |
| 263429 | Re: zzzster ocyan | zzzster | 4/20/2009 4:07:02 PM | |
| 263458 | Re: zzzster | froggmister | 12 | 4/20/2009 4:56:58 PM |
| 263474 | Re: zzzster YOUR Numbers are Crap OCYAN | ralphla54 | 4/20/2009 5:18:07 PM | |
