MNTA: (new numbers in bold)
Case 1 – MNTA/Sandoz obtains approval for generic Lovenox and neither Teva nor Amphastar obtain approval
Case 2 – MNTA/Sandoz obtains approval for generic Lovenox and Teva or Amphastar do also
Case 3 – Nobody obtains approval for generic Lovenox but the application from MNTA/Sandoz remains under consideration by the FDA pending resolution of certain issues
Case 4 – MNTA/Sandoz receives an FDA rejection of the Lovenox ANDA with no likelihood of a resubmission
Case 1: 35% 70%
2: 30% 10%
3: 35% 20%
4: 0% 0%
New rationale:
1. High confidence in MNTA
2. Where will the FDA place the bar, as discussed today on the webcast? If high, MNTA gets the only approval. How can they set the bar lower, if they know that MNTA has the purest molecule? I think the FDA must set the bar high, such that it's MNTA or no one. Only caveat: If Teva/Amphastar have an equal or better technology in-hand.
"Illegitimacy is something we should talk about in terms of not having it."
- Dan Quayle