"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