Biotech Values

[tinkershaw]

I don't know what is going on here, but it occurs to me if Teva was in "labelling" discussion a year ago, and this was well over a year after the immunogenicity concerns were raised by the FDA to begin with, then WHAT THE HECK is Teva's drug doing back being evaluated for immunogenicity issues? Should that not have been done prior to "labelling" discussions? I mean, no drug would even get that far without these immunogenicity concerns addressed.

Also, as we discussed way back then, there are no labelling issues around a substitutable generic, it takes the label of the innovator drug because that is what it substitutes for.

No, this does not add up. Doesn't mean Teva might not have the real goods this time, but if this is what Teva is saying, the rhetoric is pure B.S.

Tinker