<<10AM for the motion hearing.>>
Today the FDA's "surreply" was filed. I thought it was a pretty good response, it covers three issues: (i) whether the FDA has the authority to require immunogenicity studies. I flip back and forth between thinking the SNY argument that it does not is laughable or serious -- right now I am on laughable (but it is not clear how much weight one should give to the untutored views of a nonlitigating tax lawyer). (ii) whether the FDA;s equivalence determination was reasonable; and (iii) whether a TRO could be appropriate (responding to the argument that because the FDA has sovereign immunity, it does not take much in the way of damages to get an injunction as SNY won't be able to collect damages).
I sent a pdf of this to Dew, I expect he will add it to the collection of available documents when he gets a chance.
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