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SciClone Pharmaceuticals, Inc. Message Board

  • lov2invest lov2invest Oct 8, 2002 1:11 AM Flag

    Pegasys to be approved by 10/16

    Looks like shorty's days are numbered. Read the attached story where Roche says Pegasys should be approved next week.

    Let's see, news on SCV-07 later this week at the World TB conference; Pegasys approval next week; and our combo results the first week of November.

    Looks like we'll be moving higher soon

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    • Here's the quote for those that are lazy:

      "There is nothing out of the ordinary here," she says, adding that the company expects an FDA approval decision for Pegasys as a stand-alone treatment for hepatitis C by Oct. 16.

      • 1 Reply to lov2invest
      • And here's a couple of other quotes...

        "The scheduling of a panel meeting at such a late date is unusual...says Legg Mason biotech analyst Stefan Loren. By his reckoning, even if the panel meeting goes extremely well for Roche, it still could push back FDA action into January."

        "The only problem with this meeting is that Roche, in its guidance to analysts, has never mentioned the need for an advisory panel meeting, forecasting instead, an FDA approval of the Pegasys therapy in December."

        As far as SCLN is concerned, a Pegasys approval (pre 2005) is very important, and a delay of the Pegasys/Copegus combo approval is irrelevant at worst, beneficial at best. Roche envisions Peg/Cop as its front line drug combo against hep.C, and Peg/Zadaxin as the 2nd line (against non-responders to Peg/Cop or Peg-Intron/ribavirin. So the noise a few have been making here about how terrible it is that there is an advisory panel meeting is either misunderstanding the situation re:SCLN, or misrepresenting it, since the panel WANTS TO TALK ABOUT THE COMBO, NOT PEGASYS SOLO. Tc

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