With respect to understanding the "junk".... Could Teva obtain approval without understanding the "junk" to the same degree as MNTA? Basically - is MNTA's understanding of the "junk" the bar or the potential ceiling for the FDA?
This is just an armchair quarterback's opinion, but it would seem to me that unless Teva and Amphastar can accurately characterize all the junk, they would need to run the trials to clarify that there are no immunogenicity issues. And....given the complexity of the "junk" and the variability of the molecule, that might mean a cost prohibitive set of trials instead of just one trial. Now that the FDA has had a look inside the rabbit hole (compliments of MNTA) they won't allow "junk" science from either Amphastar or Teva.
The conundrum for MNTA is that if investors don't understand this, there will be an overhang that won't go away. The FDA may say "Gee whiz!!" to MNTA science behind closed doors, but they have neither the mission, motivation nor standing to publicize that MNTA's characterization technology is the next step in complex molecular drug science, one which they now see as the standard. I'm certain that it is governmental policy to allow the "market" to work this out, giving MNTA the opportunity to commercialize their technology. This would be far off as I cannot see either Teva or Amphastar ponying up royalties to MNTA with enough money to cover MNTA's market share loss by allowing new generics to compete.
aj
