3 enoxaparin moments from Teva call...
Question: who is the 'management' Bill Marth is referring to?
Opening statement
Shlomo Yanai
We recently met with representatives from the FDA to discuss the status of our ANDA. During the meeting, we confirmed that our version of generic Lovenox meets the FDA's criteria to demonstrate chemical sameness, and accordingly that data related to immunogenicity are currently under the Office of Biological Products.
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Q&A
David Buck- Buckingham Research Group
And then just one follow up, also for Bill. Any sense of timing of when you might see an enoxaparin response?
Bill Marth
No, I don't think we have any update from our prior comments, but as we said, we did meet with management and we do know that we've established sameness and that we are with OPD, so that's very important and we're very pleased.
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Q&A
John Boris – Citi Investment Research
...Second question just has to do with the dialog you're having with the FDA on Lovenox. Where are you in that process on Lovenox? Has it completed and you're just waiting for a final response from the FDA? Any update there would be helpful.
Bill Marth
On the enoxaparin, there isn't a whole lot more color to add to enoxaparin other than what I think is important is we achieved chemical sameness and we're in review with OPD, and meeting with management helped us feel much better about the situation.
John Boris
Is it in your guidance for this year? Lovenox?
Bill Marth
I can't really say about the guidance whether it's in or not. The fact of the matter is we are still hopeful that we could see it yet this year. In fact I'd be deeply disappointed if we didn't get the approval yet this year, but again we can't be certain.
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