European Medicines Agency Validates Gilead's Marketing Application for Ledipasvir/Sofosbuvir
Matt Chris said
Mar 28, 2014
Hey Wayne
Yes I read this article its very likely that it will be approved because their is nothing better.
What I would like to see is the FDA or some other US government agency do is Negotiate a price for these over $100.00 per pill drugs like the Individual countries do around the world.
Why should Egypt and India, China and other some countries with the same standard of living or higher pay hundreds of dollars less than the US. It just shows how the government has again failed its people.
matt
Tig said
Mar 28, 2014
In light of the US Congressional investigation into Gilead's price structure for Sovaldi, it will be interesting to follow the considerations made by Gilead in the EU and the expectations of the EU members. There should be reasonable demands placed on them after they shocked the world with Sovaldi. Obviously if nothing is done to reconsider the intial price offering to retail sources, we're sure to see a considerable increase in per dose costs. I don't think anyone outside of the Gilead organization saw the $1000/pill price of Sovaldi coming. I would require them to release such information and make a good faith effort to meet a fair release price of their sure to be popular single pill combo. If wishes were fishes, we'd all be swimming...
Tig
OldenSlow said
Mar 27, 2014
"...Although accelerated assessment of this investigational fixed-dose combination could shorten EMA's review time by approximately two months, it does not guarantee a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, LDV/SOF could be available for marketing in the EU by the end of 2014."
Hey Wayne
Yes I read this article its very likely that it will be approved because their is nothing better.
What I would like to see is the FDA or some other US government agency do is Negotiate a price for these over $100.00 per pill drugs like the Individual countries do around the world.
Why should Egypt and India, China and other some countries with the same standard of living or higher pay hundreds of dollars less than the US. It just shows how the government has again failed its people.
matt
In light of the US Congressional investigation into Gilead's price structure for Sovaldi, it will be interesting to follow the considerations made by Gilead in the EU and the expectations of the EU members. There should be reasonable demands placed on them after they shocked the world with Sovaldi. Obviously if nothing is done to reconsider the intial price offering to retail sources, we're sure to see a considerable increase in per dose costs. I don't think anyone outside of the Gilead organization saw the $1000/pill price of Sovaldi coming. I would require them to release such information and make a good faith effort to meet a fair release price of their sure to be popular single pill combo. If wishes were fishes, we'd all be swimming...
Tig
"...Although accelerated assessment of this investigational fixed-dose combination could shorten EMA's review time by approximately two months, it does not guarantee a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, LDV/SOF could be available for marketing in the EU by the end of 2014."
http://hcvadvocate.blogspot.com/2014/03/european-medicines-agency-validates.html
-- Edited by OldenSlow on Friday 28th of March 2014 03:47:30 AM