I know you are brilliant, but come on, Ed. Just because you are smart doesn’t mean everyone else is stupid. If someone can make something, someone else can make a perfect copy. This isn’t art, this is science.
Party pooper..

You know what ive been thinking…. maybe Ed should go check out the processing plant at Incepta and Beacon to put his mind at rest.

There is a patent about spray-drying technique (mentioned by Gane) for ledipasvir – http://www.google.com/patents/US20140212487 If i correctly understand, food has negative effect on absorption of ledipasvir, and spray-drying is applied to mitigate this effect. This does not mean that ledipasvir will not absorb “at all” without spray-drying. If ledipasvir is used in fasted condition – their absorption, possibly, may be good even without spray-drying…

I hope yes. Dr.Gane said that

Gilead has licenced 11 generic companies in India to produce sofosbuvir (and very soon the ledipasvir/sofosbuvir combination tablet) for the local markets. Strict quality control from Gilead ensures that these drugs are identical to those produced for European and American markets.

Well that’s good to hear Serg, +1: if a little out of date!

The Chinese manufacturer.

http://www.halosyntech.com/en/

I think Gane feels anything thats not approved by Gilead (and paying them) is suspect.
Just my opinion….

And a doctor should just keep his mouth shut if he has any doubts? He’s only saying that the chemicals from Bangladesh might not be up to scratch, not damning the properly licensed components at all, including the ones that many of us have benefited from.

By saying this:

Of particular concern is the recent availability of generic ledipasvir from Bangladesh (either separately or coformulated with sofosbuvir). Unlike the manufacturing of sofosbuvir, which is relatively simple, ledipasvir is very complex, requiring almost 20 separate steps. One critical intermediate step is Spray-Drying Dispersion, where the ledipasvir chemical is mixed with another substance to improve solubility. Without this step, the nal ledipasvir drug will not be absorbed when taken by mouth. Spray-drying for ledipasvir requires large purpose-built facilities, of which only a few exist in the world and none in Bangladesh.
It therefore seems likely that generic combinations of ledipasvir and sofosbuvir from Bangladesh will only contain active sofosbuvir. As a result, although the hepatitis C will disappear during treatment (because of the active sofosbuvir), it will relapse after treatment is stopped (because of the lack of active ledipasvir). Secondly, individuals need guidance on what treatment is best for them.

he is only talking about one particular problem that has caught his eye. Maybe you don’t like some of the implications, but if there is any doubt, I would prefer my doctor to at least air the concern.

Personally, I don’t agree with the second paragraph – if the ledipasvir was completely useless, the virus would not disappear during treatment (except for some genotypes in combination with ribavirin). However, if it was not optimally absorbed, it might make the long term outcome unfavourable for some patients.

I think he’s overstated his case, but that he did the right thing by pointing out discrepancies in the unlicensed manufacturing process that could conceivably affect the effectiveness of the drug. Better to go with the licensed generics that seem to be working so well and cost about the same for us.