Replies to post #46950 on Biotech Values

[jellybean]

<<The odds of Provenge providing a survival benefit , based on available data , are much better than the odds for Gemzar in ovarian , which are near zero , based on data on the label.
>>

and this is why you can't understand the FDA's decision. Because you "believe" Provenge works; even though the vaccine does not stimulate an immune response to an antigen in prostate cancer cells and even though the survival data is shaky -- yes, the oS number was significant for that trial. Unfortunately, the trial was too small.

[DewDiligence]

>Until efficacy of Gemzar is demonstrated in ovarian cancer (still waiting!)…<

You appear to have been brainwashed by DNDN bulls into believing that survival is the only efficacy metric of consequence in cancer.

The primary endpoint of the Gemzar trial in ovarian cancer was PFS, which the pivotal trial hit. Increasing PFS in the treated arm relative to the control arm means you are increasing the time to the earlier of death or progression. In this disease setting (ovarian cancer refractory to platinum therapy), patents are generally treated with some salvage therapy at disease progression; hence, lengthening the time to progression confers a very meaningful QoL benefit.