Replies to post #111381 on Biotech Values

[tinkershaw]

I have to strongly agree with Dew on this one. The FDA was quite clear that even small differences in lovenox would alter the drug. That is no different with Copaxone. MNTA has stated that they have fully characterized copaxone. They have proven the analytical skills to be able to do so, and to do so with methodology acceptable to the FDA to prove that they have done so.

That is a far cry from Teva with an attempt to reformulate copaxone as a life cycle product management tool.

This is actually quite bullish for MNTA. It shows that an Indian knock-off is not gonna cut it. You need true sameness, as was required for lovenox. It is doubtful that anyone else will be able to meet this standard but MNTA.

Tinker

[oldberkeley]

Dew-

Trying to understand some of the complicated science behind this, I just reread your earlier background info posts.

From one of them:

"Teva will presumably try to turn the low-volume formulation into the centerpiece of its franchise defense."

Basically, is that what's going on here? TIA.