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tinkershaw

08/05/10 12:11 PM

#100842 RE: rkrw #100834

<<<Teva President and CEO Shlomo Yanai said last week, after presenting second-quarter results, that he had good reason to believe his company was close to getting approval for its generic version of Lovenox.

The company's chief R&D officer, Benzion Weiner, also told Israel's Calcalist financial newspaper this week: "We are waiting to receive the approval soon and the chances of receiving it is high."

A Teva spokeswoman declined any further comment on timing.>>>


This is the sole source of Anderson's information. I read both quotes last week, verbatim. Others on this board did as well.

Teva may be able to work with the FDA over the coming months and get approval. Clearly, Teva has not given up on its application yet, and its application is not secretly rejected and just not disclosed.

But this analyst report contributes absolutely ZERO new information. It says "may" be approved in the coming months to end of the year. BUT WE ALL, ALREADY KNEW THAT.

In the analyst I posted last night, it did not seem likely that Teva could obtain approval if the FDA stuck to the rigor it specifed on the MNTA approval, but the FDA, after cajoling and working with Teva may institutionally become somewhat more "flexible" in interpreting its criteria. Something I stated last week. And if so Teva "may" to use the term in the Bernstein report get approval in the coming months.

But Teva also "may" not get approval. And if Teva gets approval it "may" not be directly substitutable as MNTA's approval was.

Who knows. But as I have seen over the years in biotech, it is not so much that we already knew the information, but rather what moves the share price is who eventually regurgitates it and spits it out through the proper channels.

This report is bunk, it was not even linked to Teva in Yahoo!, and is clearly a MNTA stock focused report (and not Teva in intent), but that does not change the reality that it might come to pass. Just that, this report has no more information then we already had.

We shall see.

Tinker
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DewDiligence

08/05/10 12:20 PM

#100847 RE: rkrw #100834

To be fair [to Bernstein] MNTA was approved in 6-months, which after waiting 5 years isn't far off imminent.

LOL—I figured someone would say that.

Was nvs setting prices and soliciting pre orders [in Jan 2010]?

NVS had said for many months before Bernstein’s January report that it was prepared for an immediate launch pending FDA approval, so the Bernstein report contained nothing that investors didn’t already know. The language about “soliciting pre-orders” was an attempt to make something ordinary sound extraordinary, but vacuous statements sometimes succeed in moving the market.