Dendreon was a roughie as there had never been one therapuetic cancer vaccine that made it before Provenge was approved.
FDA approval was not initially granted, but the absence of effective non-toxic treatments had a hand in it being approved.
Also, it is relevant when considering the Cvac phase II trial results that the Provenge trial patients lived 20% (4.5 months) longer - which may not seem much to healthy people, but did to patients who testified at the FDA advisory panel hearing.
As an investor, the previous PRR trials are on so few patients that it would be absurd to extrapolate the results to a bigger population, except in a speculative, size-of-market sense.
The alternative interpretations of the phase II trial is that is was mere coincidence that those receving the vaccine outlived those receiving the placebo, or that Cvac is efficacious.
That's why there will be progressively larger patient populations in these subsequent trials to establish a reliable statistical basis for assessment - or to establish that there is not any such connection.
When I consider the likelyhood of one over the other, I obviously think it does work - simply because (from a non-medical perspective), it makes sense.
You boost and target the patients' immune systems to attack specific and well-identified and accepted components of the cancer and chances are that is what will happen, to some extent. It seems to me it will be the extent of it and not the fact of it which will be the issue.
The 'extent' was probably the pivotal factor with the FDA initially delaying the approval of Provenge, perhaps later influenced by the patients who testified what the chance at a few more months of life means, subjectively.
The eventually successful passage of Provenge to market cannot be under-estimated as a factor in how the US market will appreciate the similar function of Cvac.
They have been educated both in what path the passage of a similar treatment may take and in what the outcome for early investors might be.
PRR Price at posting:
19.5¢ Sentiment: Buy Disclosure: Held
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