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pegasys
May 11, 2001

Dear Dr.,

I haven't heard anymore about pegasys. I thought it was supposed to be approved May 1. Any Ideas? Thank you

Response from Dr. Rodriguez-Torres

The combination treatment data of Pegasys-RBV will be presented next week at a meeting in Atlanta.To my knowledge there is an expedited procces going on for aproval.I think that there is good data on efficacy and safety,and the delays are related to issues of drug production and the capacity to supply the demand for drug.The other big aproval issue is that still there is no aproval for the request by Schering to "unbundle"the RBV.The request for aproval of the Roche RBV will take more time.



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