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Sofosbuvir FDA Briefing Document
For anyone who is interested here is the link to the FDA's briefing document in advance of the panel review this coming Friday 10/25. Evidently the govt. shutdown did not affect the timeline for approval. The PDUFA decision date for sofosbuvir is December 8 or 9 depending on where you look. The overall tone of this document is very encouraging for a swift approval. As a genotype 2 hoping for the all oral treatment ASAP this is very good news.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371877.pdf?source=email_rt_mc_body&app=n
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371877.pdf?source=email_rt_mc_body&app=n
yesterday they recommended SOFO for approval 15 to 0. i clicked on a article "hcv news of the day", or type in browzer.then click on CHMP. it brought up an article about compassionate use of a sofo regime for pre and post transplant patients. exciting
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