<Could you point me to one of the earlier cancer vaccines that has been anywhere near as thoroughly been proven to work? >
Since Provenge is the first anti-cancer vaccine approved, it obviously has the best data to date. It hasn't been proven to work. It has shown in small trials to provide a small survival advantage and fits statistical criteria that say the difference between it and placebo are below P=0.05. That is why I said based on the small improvement in survival and the failure to shrink tumors, that this will play out as more patients are treated.
I wrote <with regards to overall survival were not that dramatic when compared to taxotere ( ~ 4 months vs 3 months survival advantage).>
You respond with <Nowhere did I tout the survival benefit as ground breaking - because clearly it isn't. It is the side effect profile that is ground breaking.>
I object to the casual throwing around the term paradigm shift by DNDN management and investors. They use it as a bludgeon to attempt to silence critics. The small difference in survival between Provenge and placebo, and Provenge and Taxotere means Provenge is NOT a paradigm shift. It is a nice option for patients as they don't have to endure as many side-effects. One reason I don't find DNDN an attractive stock is because of the nature of Provenge. It is not off the shelf, but a personalized treatment so subjected to many potential steps for failure and delays. This many not concern you, which is fine with me. I did notice the CEO liked to use the term paradigm shift to explain away delays. That is completely irrelevant, but if it soothes you and satisfies you, that is fine with me.
I wrote the following, which has been raised by many highly qualified individuals. <it is still puzzling to many how it can show a small increase in survival when it doesn't shrink the tumors. This may be something unexpected for anti-cancer vaccines in general or Provenge specifically,>
You respond with <Neither did ipilimumab show a benefit in PFS (obviously ipilimumab is not a vaccine - but does use immune system). Yet it did show a survival benefit.>
That is great, but it doesn't mean that same is true for Provenge. If we have learned anything, it is not to generalize about different cancers. Why don't you provide me the details of the ipilimumab trial and the cancer it was being tested on so I can get a bit more up to speed?
You also wrote <As for how that might be - this is one of those things I was referring to when I said that one of the paradigm shifts is it will allow us to better understand how vaccines work:
a) Does it only block new mets and thus doesn't directly impact Progression?
b) Is it a delayed effect - and with more data we can find immune markers showing when the kick-in happens? >
That is more a what I would call better research that may help us to understand sooner if a vaccine has a chance for success, but that is hardly a paradigm shift. It sounds a bit like I cult to me when I keep hearing the term "paradigm shift" based on a small benefit. I am interested in your background as it may explain why you seem to love the term "paradigm shift" so much. Just what is it that is your field of business?
AI
