Biotech Values

[hmpa]

The slowness incurs a hidden cost on the business model of the generic applicants by forcing them to commit capital to an ANDA program before they would need to do so if the FDA acted more swiftly.

I guess if FDA manages to run a bunch of less capitalized minor generic players out of business it will be good for patient safety (only the cos with strong QA stay on), for FDA (fewer chances to get egg on its face), and for the sustainability of the generics business overall. The only losers will be CVS and WAG which get bigger mark-ups when they have dozens of competitors stomping over each other in front of their doors.