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Neurocrine Biosciences Inc. Message Board

investormdpart2 69 posts  |  Last Activity: Nov 26, 2014 12:02 PM Member since: Mar 11, 2009
  • investormdpart2 investormdpart2 Sep 4, 2014 9:51 AM Flag

    I think that depends on the form the offer takes. In other words, if an actual term sheet is presented (representing a formal offer) it will go to the BOD and then I believe there is a legal requirement. However, I'm not sure an informal offer or "discussion purposes" offer is viewed the same way. I think there is some latitude here. Most of these talks sit in the "discussion" stage for a long time before anything formal is put on paper.

  • Reply to

    BTD Research Project Anyone?

    by paladin_roams Sep 3, 2014 10:11 AM
    investormdpart2 investormdpart2 Sep 3, 2014 11:03 AM Flag

    I don't think it's possible due to all the other variable. For instance, how many of those breakthrough therapies had a second Phase 3 waved off because the data was so compelling that the FDA said one Phase 3 is enough? I know this hasn't happened in CNS before so this case is almost without precedent.

    In addition, I'm betting that a fair number of the breakthrough designations were for orphan indications.

    You're not going to find many potential mega-blockbusters with a second Phase 3 waved off that were given this status. Acadia is a rare bird and she will fly high. IMHO!

  • Reply to

    OT : A thought from an old man ...

    by smithlewis89 Sep 2, 2014 11:17 PM
    investormdpart2 investormdpart2 Sep 3, 2014 9:21 AM Flag

    Haha, awesome. Take care.

  • Reply to

    OT : A thought from an old man ...

    by smithlewis89 Sep 2, 2014 11:17 PM
    investormdpart2 investormdpart2 Sep 3, 2014 12:33 AM Flag

    Haha, well maybe I have too much time also! I actually sat here and calculated your shares and profit. You made that into a fun math problem so I had no choice! So you have 28,000 shares and you made $73,641.28 today. Well done!!

  • Reply to

    Breakthrough Therapy Designation

    by lennox64 Sep 2, 2014 5:01 PM
    investormdpart2 investormdpart2 Sep 2, 2014 10:25 PM Flag

    Thanks. Yes, I've been around and am always watching Acadia closely. We're starting to see things line up now. I'm looking forward to the actual NDA filing and then a Priority Review designation. It's not guaranteed but I believe that it's highly likely and the Breakthrough Therapy Designation today increases my confidence. A clock is now ticking and we haven't really had that with Acadia before. In the next four months the NDA will be filed and we may see additional clinical trial launches in areas such as schizophrenia and perhaps something in the sleep/wake area for Parkinson's patients since Pimavanserin clearly has a very positive impact here. Early 2015 will likely bring news regarding Priority Review which should set the stage for a lot of excitement going into the approval decision which I believe will be before the end of summer 2015. I don't have a price target, but it's certainly far north of where we are today. If we become a so-called bolt on the terms should be excellent with contingency rights should ADP, schizophrenia and other indications pan out. Exciting times for sure.

  • Reply to

    Breakthrough Therapy Designation

    by lennox64 Sep 2, 2014 5:01 PM
    investormdpart2 investormdpart2 Sep 2, 2014 5:22 PM Flag

    In other words, priority review is highly likely. I remember when risperidone was approved in 1994....20 years later a newer generation antipsychotic is finally ready to face the FDA. We all know how much revenue the atypicals generated as a class...it's around $14 billion for those who don't know. There is only one Nuplazid...no other class members to share this market with. Yes, we will only be approved for PDP at first, but Nuplazid will of course be looked at for ADP, schizophrenia and bipolar. Off-label and expanded label in CNS is almost a given because so few new drugs are approved. I have been waiting a long time for the next generation to appear. As an investor, Acadia is dreamy.

  • Reply to

    The Big RED Candle.

    by crecy_war_knight Sep 2, 2014 10:12 AM
    investormdpart2 investormdpart2 Sep 2, 2014 12:35 PM Flag

    I honestly have no issue with shorts making money where they can. I have my long term capital gains locked in here and I'm not budging from my position. Having said this, deals (M&A and licensing) will be heating up for all biopharma groups in the coming months. Summer months slow all discussions, but things tend to come together in the autumn. I'm still not convinced that an offer won't appear. The Breakthrough Therapy Designation will make an acquirer that much more confident that approval will happen. Priority Review is also likely IMO. Of course, if we get a six month review (likely in my opinion) we could be talking about approval in the summer 2015. Once the NDA is filed there will be a long line of catalysts to look at. It's going to be a really exciting 2015 if Acadia can stay single that long. We'll see. They're looking gorgeous and everyone knows it.

  • Reply to

    The Big RED Candle.

    by crecy_war_knight Sep 2, 2014 10:12 AM
    investormdpart2 investormdpart2 Sep 2, 2014 11:45 AM Flag

    Start adding together terminology like "Bolt on Acquisition" from Cramer, reality like "Breakthrough Therapy Designation" and maybe even "Priority Review" (which is coming in my opinion within 60 days of NDA filing) and the shorts have so much to worry about. Not only is Acadia performing on all levels, but outside acquisition forces and FDA actions can rocket this quickly. Shorts are more than worried.

  • Reply to

    Buy now at 21 or pay 25 in 2 months.

    by prs_hope Aug 6, 2014 11:10 AM
    investormdpart2 investormdpart2 Sep 2, 2014 11:40 AM Flag

    I would just again reference my above post since I personally believe a Priority Review is also quite likely. This would happen within 60 days of the actual NDA filing.

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