Biotech Values

[iwfal]

The FDA’s published guidance for what is required for approval of generic Copaxone will probably end up being taken from MNTA’s application, as was the case with Lovenox.

I don't remember seeing anything from MNTA describing in any particular detail (prior to the FDA responses) what it is that Momenta thought was important in characterizing Lovenox. That was then later parrotted by the FDA in their response to the Sanofi Citizen's Petition. I can think of several places it might have happened (e.g. in some investor conference call slides, a set of technical papers or some discussion about their work on the heparin scare) but haven't found it on their site. Do you have any pointers.