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steveporsche

04/11/08 3:04 PM

#5632 RE: DewDiligence #5631

"If the welfare of cancer patients were the main issue, wouldn’t you want DNDN to wait for another 56 events (360-204) in order to give the trial the best possible chance to succeed?

From a patient-advocacy standpoint, surely the delay in obtaining 56 more events pales in comparison to the nightmare scenario where: a) Provenge really does have good efficacy; b) the new 9902b trial fails; and c) the old 9902b trial would have succeeded."

You describe my nightmare - I wish they would have left the trial alone and waited for those hopefully 56 high HR events. Obtaining financing certainly those not seem to be a problem for them. Waiting another 6 to 12 months would not have been such a big deal since the trial has already been going on for nearly 5 years.
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croumagnon

04/11/08 3:16 PM

#5633 RE: DewDiligence #5631

"From a patient-advocacy standpoint, surely the delay in obtaining 56 more events pales in comparison to the nightmare scenario where: a) Provenge really does have good efficacy; b) the new 9902b trial fails; and c) the old 9902b trial would have succeeded."

I agree with you. The SPA change made sense regarding the interim, to give it a better chance, however shrinking the timeline of the final by a few months to sacrifice some chances for meeting the goal was, at best, a foolish endeavor. I also agree with your previously stated opinion that the whole final change is a bit suspicious and hinting to the fact that DNDN was aiming to keep investor interest during that period of time rather than trying to help the patients...
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p3analyze

04/11/08 3:23 PM

#5634 RE: DewDiligence #5631

"obtaining 56 more events pales in comparison to the nightmare scenario where: a) Provenge really does have good efficacy; b) the new 9902b trial fails; and c) the old 9902b trial would have succeeded."

How do you think FDA will react if the new 9902b trial fails to show a statistically significant benefit, but upon 56 more deaths that it swings the p-value to below the magical 0.05 level. Will you be certain that FDA will reject study 9902b altogether?