Their review was in October, nothing has changed. Approval should be around December 9th as planned. I would guess they would be on the market for use around the first of the year as it wasn't long once the current PI's was approved...........
The FDA review meeting was Oct 25 and all members voted unanimously to approve the drug, that was their recommendation.
In fact, I heard they went a step further, but I think it would be best to just wait and see what the FDA approves.
Gilead already has a strong relationship with the VA and they sounded very positive and ready to dispense & start treating.
I don't think the issue will be with Gilead, if there is a slow start or delay it would be with the VA. When the drugs roll out it may not be the same day that the VA starts dispensing.
My understanding is that the FDA has until December 8 (a Sunday!!) to approve or reject. I wonder if it could come sooner.
When the PI's were first approved people I know had them almost immediately. I would be very surprised if the drugs rolled out slower with this release.
Gilead has been in the news all weekend releasing their data results for all oral Sofosbuvir (phase 3) Hep C and co-infected w/ HIV. Also released GT3's data Hep C. Also Phase 2 results of Sofosbuvir before and after transplant. If you go to www.gilead.com and then go to press releases you can read all of the information. One thing extremely interesting about this company is that on 10-29-13 they released their earnings for the quarter. Analysts expected .48 cents per share earning which in fact it was .52 on $2.78B (yes that is billion) which is amazing. Their "forward guidance" was consistently increasing. So I would think the FDA's approval is right on track.
anything new for HCV1a never treated
This certainly gives hope for all HCV types