Gilead's (GILD) Sofosbuvir FDA Panel Review Date Set for October 25th

[hoblonggotta]

Does anybody know if data from Gileads  drug trial Sofosbuvir and gs5816 will be released @ the Oct 25 meeting. Does anybody know when that data will be released.

[Dee1956]

Hector is right, with the govt shutdown this review will probably be help up.  I hope they open the govt back up.  There are many suffering...not getting medications because of this shut down.
I have noticed shortage on the shelves in our area.

I am sure there will be an update as soon as the govt reopens.
Here is some info on the Simeprevir which I thought the FDA would look at first.
Good luck

http://www.hepatitis-central.com/mt/archives/2013/07/simeprevir-will-most-likely-be-approved-by-the-fda.html

[johnny679]

Sorry what do you mean by this statement ? are you meaning the potential dramas over sofosbuvir rights  with merck qeez hope they can work something out to avoid any delays for all


Should the government shut down for any length of time the FDA review could be delayed.

[HectorSF]

This meeting is to discuss the treatments for hepatitis C that Gilead has submitted to the FDA for approval in April of this year.

Gilead filed the NDA (New Drug Application) for sofosbuvir on April 8, 2013. The data submitted in this NDA  support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naive patients with genotype 1, 4, 5 and 6 HCV infection.

Should the government shut down for any length of time, the FDA review could be delayed.

Sofosbuvir and gs5816 full data is released at the EASL or AASLD meetings and when the combination is reviewed for approval by the FDA. Top line data is released by Gilead. First the clinical trials must be completed and data compiled.

Hector