IMHO, if for some unbeknown or known reason (Dendreon's experience with corruption), the FDA rules against CVac leading ultimately to more rapid rates of death, then not only should/would legal action against the FDA ensue, but it would expose the FDA as nothing more than purveyors, or more accurately: ARBITERS OF DEATH.
Because the way I see it, it would surely defy both precedent (Provenge) and logic (unmet need, non-toxic nature of treatment).
If Yervoy can be catapulted along the path towards commercialisation (with all its known deleterious side-effects), questions of the FDA ought, and must, be asked.
If I were Martin Rogers, I'd be taking preparatory steps to ensure I had the best legal minds available if the unthinkable happens.
Because, in all sincerity, only the FDA stands in the way of CVac achieving all its stated commercial and medical aims.
If CVac were a completely different scientific animal to Provenge, and one in which alternative treatments were readily available, I could understand the additional required rigor.
But as we stand here today, in possession of all the "known knowns," the FDA nor any other drug agency can rule against it.
And so it is on this basis that we invest accordingly.
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