Biotech Values

[Bio_pete]

TEVA - I can't understand how the FDA's statement on low volume Copaxone won't impact MNTA's generic approval.

"The FDA noted that the 0.5mL formulation contained the same active ingredient as the currently marketed Copaxone®, but that because the mechanism of action of Copaxone® is not fully understood, even a formulation change could impact clinical outcomes."

Wouldn't MNTA's formulation be considered a change even if contained the same active ingredient? Count me into the hoodwinked group.