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You'd think that'd be a simple question to answer, but it's not.


PW stated in the Annual Report that the company is awaiting a decision on Priority Review by the FDA. This implies Priority Review has already been applied for. I believe that is usually that is only done when the NDA has been submitted. On that basis some have speculated that we could see a decision on the NDA within the next few weeks. Other comments by PW suggest the NDA will in fact be made late this year/early next.


Once the NDA is submitted there will be a 2 month validation period, with the review itself taking up to 6 months (if priority review granted) or 10 if its not.


So, FDA decision on the NDA could be from now till Dec next year, depending on where you think we are in the process.


To me, interpreting the ambiguity of the various statements, August 2018 seems most likely. If earlier......great.

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FDA , a very conservative Institute. Cooperation is the magic word. FDA/ EMA, 2 cooks in one and the same kitchen, that's one too much!. It's time they fuse together. New Headoffice Europe.


CUV is clearly orchestrated, that's a fact. This "new" decline to new lows $8,77 is a clear signal that She isn't allow to pass the $9 (resistance level). Next week you still can buy them very cheap, below the $8,90 all week long..


In my believe it's a clear signal that the Market isn't convinced that the AGM (PW) will bring more clearance, that there is a big change that it will be a no news show again as we've experienced so many times...

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To have 16 weeks taken off of the wait with a so called ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“priority reviewÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ (longest approval process in history for one of the safest most effective drugs) would be an insult after all the years wasted waiting for ignorant overly paternalistic bureaucrats to sign off on this safe and vital drug.

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You know why it takes so long? IT gives you a TAN! I can imagine that the Pharmaceutical Industry isn't very pleased with the outcome of the EMA.


I personal think that their is an (anti) Lobbying going on by this "Industry" at the adress of the FDA.


PW has done a great job and still does. He know sexactly how to deal with these obstacles. Yes, in this case I'm not surprised that the whole proces takes longer then usual is the case. Perhaps that's the main reason why PW keeps his mouth shut. Everything what you're saying right now can be used against you!


Open communication? I think PW certainly will give us more clearance, not at the 28th of this month but he waits for the outcome of the FDA first.Very clever. Untill then I think he has put himself in the silent mode.


Hopefully the sales in Europe are doing well right now. That's what counts right now.

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