Biotech Values

[jq1234]

If Teva feels it has a generic lovenox and it gets stonewalled by the FDA then maybe Teva would have justification to run those trials if it could use the data for both the EU and US approvals.

I didn't miss your point because your point didn't make sense. Do you know the regulation for generic approval under ANDA in US? You can't run clinical trial for generic approval in US. If Teva runs trials for EMEA under biosimilar regulation, then uses the data for US, then it can't apply under ANDA in US. It doesn't concern MNTA in that case.

As far as my negative opinions, the only reason I throw them out is because no one else does.

There are. There are people who believe Teva is going to get approved in the future. The difference is they don't throw nonsensible negative opinion.

what are the chances that the FDA moves the goal posts? Keep in mind they moved them once already when dealing with Lovenox.

Sure, it is possible, but not any time soon because they just put the criteria out, and is using it in court against SNY. I don't consider this question from you is nonsensible, by the way.