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
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”