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Decision to Start Peg?
Nov 29, 1999

Dear Dr. Dieterich,

I understand you are currently doing trial studies on some of your patients using Peg. If they are currently on a list, what factors do you consider for those patients to start Peg trials. I heard through the net that this drug is very promising but probably won't be approved for another 2 years. Do you know anything different? Are the patients on the list considered not as critical and therefore does not need to start treatment.

Your feedback would be most appreciated.

MM

Response from Dr. Dieterich

Dear MM, The Pegylated interferons are being studied now in phase III studies. Both Schering and Roche are doing studies. Roche is doing 2 studies in HIV/ HCV patients, one an international trial and one in the US. Generally, the sites in the US are limited to 9 patients that meet the inclusion criteria. Both companies plan to submit the NDA to the FDA soon, so they should both be approved in calendar 2000. Good luck! Douglas T. Dieterich, M.D.


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