Biotech Values

[mouton29]

<<I just read the opinion. I posted a few messages over the last few days analyzing SNY's PI motion and why I thought it was "bunk". (see my posts below) The court agreed on both counts! Yea for MNTA longs!>>

The judge came very close to quoting the first sentence of the first post you reference, where you said "SNY's interpretation of the statute is joke"

However, his technical holding was not that the immunogenicity testing was justified under the "bioequivalence" clause in 505(j)(2)(A)(iv), rather that the testing was justified to assure purity, under 355(j)(2)(A)(vi), which requires a full description of the facilities and controls used for the manufacture and 355(j)(4)(A), requiring the FDA to determine that the methods and facilities are sufficient to assure purity (among other things).