Dew,
On the early filing of telaprevir in the second line setting. Perhaps may the thought be that since there is already so much data out there that doctors will not limit use of telaprevir to the second line treatment and will also use it for first line treatment as well?
I mean, if you are a knowledgeable physician, you've followed the clinical results, you already know that telaprevir works, you know its side effects, you can already garner protocols to deal and mimize side effects, and you know as an ABSOLUTE AND UTTER FACT, at least as much as you probably ever will, that the telaprevir regiment, whether first or second line is superior to the existing SoC and by quite a large margin.
As such, it seems more administrative rather then to anyone's medical advantage to postpone approval of the drug on either first or second line pending phase III.
This said, the argument is even stronger to the greater need second line setting, even though the second line data is sparser than the first line data.
Could it very well be that the FDA prefers not to give any anticipated large scale off-label usage, and therefore, on this basis alone, will defer approval for second line usage?
It is the sort of thing that bureaucrats are apt to do, although it makes little practical sense.
Tinker
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