Thanks, elmono. I printed the document and will read it carefully.
On an initial cursory examination, it looks to me like this document refers to the proposed regulatory framework for generic biologics; i.e., products that can be substituted at will by a pharmacy or other supplier for a branded biopharmaceutical.
To my knowledge, GTCB is not seeking a substitutability claim for ATryn vis-à-vis plasma-derived antithrombin, nor is it economically important to have such a claim. Regards, Dew
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