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DewDiligence

04/11/11 12:23 PM

#118045 RE: jq1234 #118044

Re: Telaprevir approval in China

Let’s recap. In #msg-61915110 you said;

China and Japan have their own drug application processes. FDA and EMA approval doesn't mean approval over there any time soon.

I pointed out that the Telaprevir NDA is Japan was submitted three months ago (which you evidently did not know). It follows that approval in Japan is not some distant event, but rather something that could occur in late 2011 or early 2012.

Then, in #msg-61919319 you said:

They can't even file for [Telaprevir] registration trial in China until it is approved in US.

I pointed out that this is false.

Now, in #msg-61936495 you say:

…[Telaprevir] needs to be approved in Japan first before applying for import route to China.

This is entirely consistent with Telaprevir approval in China by the end of 2012, which is what I’ve been saying all along.