Replies to post #5430 on Dendreon Corp fka DNDNQ

[rancherho]

Statistical question: If DNDN has in fact used the Haybittle-Peto method to allocate an interim aplha in 9902b, and the resultant required P value to beat is 0.001, this might be a great question that David Miller or some other analyst to ask at the next quarterly CC. If the expected: "We're not releasing that information" comes up, a follow-up question might be: "Why shouldn't every shareholder / owner be entitled to an answer?" After the entire FDA Form 483 non disclosure fiasco, DNDN's management could use some practice in the trnsparency area.

[ocyanblue]

IMO, the difference in results is so dramatic between the Povenge only results and the combination results that it will be reaffirned in 9902b.

Although I do think that the Provenge+Taxotere effect is believable, esp given a number of NCI publications on Taxotere+various vaccines, there are sufficient unknowns in how Taxotere would be taken in the trial for us to be so sure of a stat sig result based solely on that possibility. For example, caseystarman reported that his friend who was randomized onto the control arm took Taxotere before Frovenge.

The conservatism of the Haybittle-Peto boundaries at the interim analyses came from applying a uniformly stringent criterion, with a nominal P-value of 0.001, at all interim analyses." If the Haybittle-Peto method is used in 9902b as well, would this reduce your assessment that the interim might be successful?

I do not have the software to compute the interim nominal alpha for Haybittle but if it's .001, the chance of meeting stat sig will be very low. For OBF, the nominal alpha is a direct function of the trigger number, the higher the trigger, the higher the alpha. So if OBF was used for 9902b, the chance of stat sig will be a function of the trigger.