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Friday, 02/10/2006 2:36:50 PM

Friday, February 10, 2006 2:36:50 PM

Post# of 252571
Prudential’s take on TELK:

[c/o marthambles on SI]

>>
Astonishingly, “events” in ASSIST-1 and -2 have also been slow to arise in concert with the delayed progress of ASSIST-3. We find it difficult to understand why “events” in the two Phase III trials have been slow to emerge because historical data tells us that ASSIST-1 should have generated enough “events” (deaths) by now.

We think it is somewhat magical to have three different trials, for three different indications, based on three different sets of end points, initiated at three different times, and with three different expected accumulation rates to have data at about the same time. But nonetheless, during the conference call, the company said that the data from all three trials could come out in either Q2 or Q3 of ’06 [emphasis added].

As a result, we are pushing back our projected NDA submission timeline to Q4’06 and possible approval date to 2H’07.
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