How long does it take to get approval? They have started the Insurance and said that it would take a couple of weeks for the insurance. What happens after the insurance is approved? How long for the testing process?
I believe the general consensus is sometime towards the middle/end of next year. They have filed for "fast track" approval - so that means it should only take about 4x times longer than it really should, instead of 8x longer.
//www.thestreet.com/story/11929167/1/2013-fda-drug-approval-calendar.html?cm_ven=GOOGLEN
Gilead Sciences
Drug/indication: Sofosbuvir, hepatitis C
Approval decision date: Dec.
Hello - I am genotype 1a, I had a liver biopsy in February 2014 that showed stage 2 grade 2-3. My IL28B is TT. I found out in Oct 2013 that I relapsed after 48 weeks of triple therapy with Incivek. Prior to that I was a twice non-responder to Interferon and Ribiviran. I've had this disease since 1987 as far as I know.
Today my GI is starting his efforts to get me approved for Harvoni. I'm not sure if I'm considered sick enough for approval or what. I guess I'll find out.
I am happy you have gotten approval, please keep in touch, let everyone know how you are doing.
You're dealing with anxiety. I might suggest you google the phrase "childhood anxiety" or something similar to find information on dealing with this issue. It won't go away over night, but your daughter's self-esteem can be heightened with intervention ideas. By the way, is your daughter extremely "sensitive"? If she is, I might suggest a book written by Elaine N.
http://www.huffingtonpost.com/2013/03/06/obama-approval-rating_n_2816045.html?icid=maing-grid7|main5|dl11|sec1_lnk3%26pLid%3D279165
Looks like this may be a sign of the times. Everyone is upset and seeing this for what its worth. Too many stubborn people in DC.
In my experience, a week after approval I received my meds from the specialty pharmacy fed x overnight but not before they called (spec pharm) and asked a slue of questions, and then they had me call again to order and they asked a couple more questions. Couldn't start the meds until I had a "teaching" from my NP. I started today actually, am doing 4week lead-in with Peg/Riba and then Victrelis. Good luck on your journey and congrats on going to get started.
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?
You may never get her approval. Trust me I have *** hole in laws n it is always something. And when the baby is born she'll feel like a douche. Don't let her bring u down. N don't surround yourself by non supportive people. U don't need it.
- http://en.wikipedia.org/wiki/Exenatide.
Getting control on the right-for-you medication is not easy. I have beed T2D since 2007 and have been on a number of different Meds, some of which seemed to work but then longer term had problems. You must keep you chin up and work with your dr. to find the best contol for you.
Good luck!
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