RE: timeframe5 Oct 2017 10:35
No one has any information on China or Hong Kong apart from what's written in the announcements.
HK is meant to happen before the end of this year, however. Since nothing seems to have been mentioned in the announcement a couple of days ago, although China was, I'm pretty certain it will be delayed (based on historical events). But we still have 3 months yet so I could end up eating my words.
The FDA approval, in my mind, could have been now if they had started the process back in 2013. The market were informed of ongoing regular discussions with the FDA, so why it took so long to decide what they needed beats me. Obviously JG would argue that they were pursuing the 6 dose can route, however, they could just have easily started with the 20 dose can and gone for a variation.
And what do you know, they have ended up going down that route anyway and at a cost of nearly 3 years loss of exclusivity. Amazingly they stated it's better to go with the 20 dose than the 12 dose, what a complete waste.
I think the only way it could be sped up is if Trump got involved, but he's far too busy tweeting the rest of the world....LOL
At least we now have the EU launch to look forward to and possibly .... and Ill write that again... possibly one or two ROW licenses sometime next year.