Replies to post #115930 on Biotech Values

[tinkershaw]

Unless Teva wants to launch at risk (which presumes they don't have much respect for this lawsuit) it is hard to see an interpration of this that is negative for MNTA vis a vie the near-term prospects of t-enoxaparin approval.

Tinker

[rwwine]

Thank you Dew. Not surprising, but very nice to get confirmation I would say. :-) Minimum of 8 more quarters of unfettered m-Lov maximum profit.

[ThomasS]

MNTA: "Therefore, the fact that Teva has agreed to a drawn-out timeline in which a trial could not start until 2013 suggests that Teva has no expectation of getting FDA approval in the next two years."

I believe what may be lost in this discussion is the obvious fact that NVS/MNTA must also have no expectation of Teva garnering an imminent approval. Didn't NVS/MNTA have to agree to the timeline?

[HattieTheWitch]

...the fact that Teva has agreed to a drawn-out timeline in which a trial could not start until 2013 suggests that Teva has no expectation of getting FDA approval in the next two years...

Excuse my denseness, but I read the entire document you linked to and I can't figure out how you arrive at the conclusion that TEVA doesn't expect FDA approval in the next two years. Can you explain your rationale?

Unless I'm totally misunderstanding things, (which, when legal matters are involved is more than possible) TEVA has managed to kick the can more than a year down the road - which I count as a win for TEVA - and I imagine they will portray it as such.

Heck, why wouldn't TEVA celebrate? A guarantee of no trial for 1+ years equates to no expectation of t-enox approval on TEVA's part?

I'm plain mystified by your interpretation.

Thanks in advance for your reply.

[investorgold2002]

why would teva agree for such an extended time line ?

even if TEVA get's FDA approval , it is unlikely it will launch at-risk at least until it knows the legal risk (which I would presume it would know ONLY after the discovery phase is complete) ?

[DFRAI]

Dew - how long before the mute,deaf, blind analysts get a hold of this positive Lovenox trial deal?????????????????????????

[DewDiligence]

A trial date in NVS/MNTA’s patent-infringement suit vs Teva is provisionally set for February 4, 2013. That’s not a typo!

I continue to stand by the following statment from #msg-60638698, which was posted a few weeks ago:

We may presume that NVS/MNTA would ask the Court for a preliminary injunction against Teva in the event that Teva were to get FDA approval for generic Lovenox. Therefore, the fact that Teva has agreed to a drawn-out timeline in which a trial could not start until 2013 suggests that Teva has no expectation of getting FDA approval in the next two years. For readers of this board, this is hardly surprising, of course.

Here is the document filed with the District Court today:

Click here

See page 7 of the proposed scheduling order.