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Dendreon is just beginning to test her wings. It won't be too long (a matter of months, not years) until she actually knows what it's like to fly. :)

But, far more important than the profits to be made, is the desperately needed hope that Provenge can bring to those suffering from advanced stage prostate cancer. Provenge already has FDA fast-track approval status, but let’s hope they ramp that approval track up a notch, for what is generally termed ‘humanitarian’ reasons. Right now, it appears that BLA filing could occur late this year or early next, with possible FDA approval by mid-2006.

I was ecstatic to read, in today’s announcement, that the Cox statistical regression analysis (on PSA, number of bone metastases, etc.) for 9902A returned the same results as 9901. And, as if that weren’t sweet enough, the trial segments were balanced in favor of the placebo receivers. If it isn’t already, the Cox analysis should be a weighty factor in approval considerations.

Bottom line: Dendreon now has two phase 3 trials under its belt in which median survival benefits proved to be better than those of Taxotere (the only FDA-approved treatment that extends life in advanced-stage patients).

Not necessarily a cure, but a very significant step toward one, and … most important … new hope for men who, up until now, have had little to cling to. We can, and must, be patient in waiting for significant profits. Patience is not a luxury they can afford.

~ joanie