Oh no, its help get the word out , gives all the FDA info, including Black Box , prescribing info etc, It will have nice pictures and will attract those who have Parkinson's patients to start thinking about " Oh, there's a drug for that now ". Its a cost of doing business and well worth every penny.
I suspect Nuplazid is so new there are other specialist who will learn about it and be prescribing it by July. I get a few medical journals and haven't see on Nuplazid ad yet. Give it time. Investors in Biotech learn about new drugs sometimes sooner than the doc's in practice.
OK thanks for the info...12 mos. I hope you are wrong and its sooner, but I think they can still get close to a 1 Billion Rev in approx 2 yrs.
1) BUY OUT- Who knows when this could occur, but it will make your head spin when it hits.
2) Launch USA Nuplazid in June 2016
3) AD Psychosis Phase 2 Proof of Concept trial - Enrollment completed Mid 2016,
4) AD Psychosis Phase 2 Top line data reading out in the Q4 2016
5) AD Agitation Phase 2 on track to start Q2 2016
6) EU - Marketing Authorization Application (MAA) but still waiting for the Pediatric Investigation of Plan (PIP) waiver-this could take 4 mos, but I would bet no longer than 60d to get the waiver. Guessing EU Launch could occur in less than 6mos. Davis will provide updates on this issue.
I don't consider most Presentations a "catalysts " unless news is expected. Please feel free to make other suggests to my list. Less
But the EU MAA delay ,ie, no PIP Waiver notice was given to Acadia the day before the Pricing was made public. The EU didn't have a clue what the price was going to be. Forgive me, but maybe I am not understanding you.
I looked around on ema (dot) europa (dot) eu, but not to worry let us assume you are correct and I missed it. Point is Acadia is going for a Waiver.
Type Value Conf.
resist. 39.25 2
resist. 36.06 4
resist. 35.23 2
resist. 33.98 5
resist. 32.55 6
resist. 30.16 5
supp 28.30 5
supp 25.69 2
supp 24.52 2
supp 23.63 2
supp 21.76 2
supp 20.89 3
supp 19.23 2
supp 17.32 4
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Mr justin I see your name too, but I guess i put your bung on Iggy too. I can't recall, its hard keeping track of all the inmates. Say hello to davi and PP, and rat for me. Have fun welcoming davi to
General Population....FRESH FISH ! FRESH FISH !
Yes, after the military I was a GP and retired 2013. As far as I know for the EU if they want to get an indication for PDP in adults, you either have to satisfy the PIP or get a Waiver. There is no "deferral" process as you say. I would think try to get as many Adult indications as possible first. Peds later.
I mentioned it several different posts. Its not a major thing. I guess the EU has a requirement of the PIP or waiver. We need the waiver to then provide the MAA to the EU which is like a NDA to the FDA .
The Pricing. See article "" Acadia Pharmaceutical's Nuplazid Pricing Is Good News for Shareholders ""
By Michael Kramer. So just that one thing moves the stock up together with being Over Sold. I would think we see another nice move once we get the PIP Waiver which will allow the company to move forward with the MAA - EU Launch.