Biotech Values

[ThomasS]

TEVA(MNTA): "It is Teva’s intention to submit the PD study results for Agency review as part of our pending ANDA for enoxaparin sodium injection."
---Note usage of the key operator "intention."

...unless they were referring to in vitro testing, we know PD studies cannot be used to support a non-AB rated generic

---It is unknown what the FDA will allow. The thread involving Teva possibly getting a non AB-rated approval is still valid, imo. The thread involving Teva walking away empty-handed (and not caring) is also alive.