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Amgen Inc. Message Board

crecy_war_knight 6397 posts  |  Last Activity: 1 hour 55 minutes ago Member since: Jan 25, 2007
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  • Reply to

    Hehehehe

    by iflippforprofitt 3 hours ago
    crecy_war_knight crecy_war_knight 1 hour 55 minutes ago Flag

    You didn't even short it. You didn't make a penny, so get lost.

  • Reply to

    In the FDA hands now.

    by crecy_war_knight 3 hours ago
    crecy_war_knight crecy_war_knight 2 hours 57 minutes ago Flag

    Think then 1-2 month for FDA acceptance, 4-6 month for approval, Feb 2016 soonest-May 2016 latest for Drug approval. Can re-calculate upon NDA acceptance.

  • crecy_war_knight by crecy_war_knight 3 hours ago Flag

    So now the FDA has 60 days to accept or reject the Application, Then if the FDA can give this a "Priority Review" status. Without it the Prescription Drug User Fee Act ( PDUFA) date can take up to 10 months, with Priority Review, 6 months. I am thinking because this is a very unmet need, and their is No Drug Indication for Parkinson's Disease Psychosis, the date will be sooner than 6 months.

  • crecy_war_knight by crecy_war_knight 3 hours ago Flag

    He no doubt was offered the CEO position based on his ability to get the NDA done. Let me be fair minded here. I don't like Davis for reasons mentioned in the past regarding the last NDA delay. But I will put that behind me now and hope he can carrier us to Drug approval, BO, Partnership, EU NDA etc. He is a lot stronger of a man than I believed. The Peter Principle notwithstanding, I will give him all my support..

  • crecy_war_knight crecy_war_knight 3 hours ago Flag

    This #$%$ wHOLE spams his junk stocks over and over again and has the nerve to make this dimwit post. Keep in mind Confucius, WHAT GOES 'ROUND, COMES AROUND.

  • crecy_war_knight crecy_war_knight 4 hours ago Flag

    not only did many shorts miss the bottom, many only covered half their shares thinking tomorrow would be another drop. We'll see.

  • Reply to

    ACAD Review.

    by crecy_war_knight 8 hours ago
    crecy_war_knight crecy_war_knight 4 hours ago Flag

    It's "Sell The News", but strong hands hanging around for up coming catalyst to get knocked down one by one. Sellers today will be buyers tomorrow. Not worried.

  • crecy_war_knight by crecy_war_knight 4 hours ago Flag

    7 cents off the lows. Shorts trying to cover. Weak hands snookered out of their shares. Nothing but Market Maker tree shaking. Nothing fundamentally wrong with the science or the company. On track to be a Billion dollar Drug.

  • Reply to

    Is missling selling shares?

    by heatherp1114 5 hours ago
    crecy_war_knight crecy_war_knight 5 hours ago Flag

    Jul 14, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.52 per share. 520
    Jul 13, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.53 per share. 530
    Jul 7, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.51 per share. 510
    Jul 6, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.47 per share. 470
    Jul 1, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.45 per share. 450
    Jun 30, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.44 per share. 440
    Jun 23, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.47 per share. 470
    Jun 22, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.42 per share. 420
    Jun 16, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.44 per share. 440
    Jun 15, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.43 per share. 430
    Jun 10, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.36 per share. 360
    Jun 8, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.35 per share. 350
    Jun 4, 2015 MISSLING CHRISTOPHER UOfficer 1,000 Direct Automatic Purchase at $0.37 per share.

  • rookie mistake.

  • Reply to

    what a joke:

    by cabogordon 7 hours ago
    crecy_war_knight crecy_war_knight 6 hours ago Flag

    I am hoping this is the start of a nice up trend.

  • Reply to

    what a joke:

    by cabogordon 7 hours ago
    crecy_war_knight crecy_war_knight 7 hours ago Flag

    Well the day is not over yet little Miss Impatient.

  • Go it alone? I know it seems like it's on auto-pilot, but the company still has to submit a NDA to the EU probably next year and they have to start thinking about distribution not just to the USA , but World Wide. Thats a huge task and expense.

  • Reply to

    ACAD Review.

    by crecy_war_knight 8 hours ago
    crecy_war_knight crecy_war_knight 7 hours ago Flag

    Priority Review is a no-brainer. The FDA has been waiting for this drug for a long time. Very unmet need and frustrating condition to treat.

  • crecy_war_knight crecy_war_knight 7 hours ago Flag

    You are so full of it, new alias for an old Short.

  • Reply to

    ACAD Review.

    by crecy_war_knight 8 hours ago
    crecy_war_knight crecy_war_knight 8 hours ago Flag

    So how much could they make ?
    1000000 PD patients...approx 40% will get PDP. So thats 400,000 PDP patients. Price for Abilify is 13K/year...I think NUPLAZID will be higher...guess is $15,000/yr ( ~ $40/day). Now lets say of those 400,000 patients, only 20% get placed on Nuplazid first year. That's 80,000 patients on treatment....so 80,000 x $15,000/yr, so for the first year, we are talking 1.2 Billion with only 20% penetration. Remember , this does not take into consideration OFF LABEL use for any other condition or if /when it may get an indication for another type of psychosis/ sleep issue/ Autism etc. Now consider there are 1.6 million PD patiens in the EU, and 640,000 will get PDP at some point. We are talking way over a Billion in the EU also.

  • crecy_war_knight by crecy_war_knight 8 hours ago Flag

    NUPLAZID/Pimavanserin is ONE OF A KIND, FIRST IN ITS CLASS drug to treat Parkinson's Disease Psychosis (PDP). And ACAD owns the World Wide Rights to it. The FDA has already reviewed the Phase3 research data and given ACAD thumbs up to proceed with the New Drug Application and has given Pima " Breakthrough Therapy Designation " USA sales will be over 1.1 BILLION and European Union will be well over a Billion as well. There are several other ongoing studies.. The manufacturing arm of the NDA is getting the close attention it should of had last year- it will take some time for new directors & CMO 's to get the systems ready & on line for the FDA evaluations. ..Review the catalyst list-

    1) New CEO -SEPT 3,2015-Steve Davis as President and Chief Executive Officer. - who can led us to Drug Approval and move the company forward.
    2) Possible Partnership with a MAJOR drug company that will assure the NDA will meet and exceed all the FDA standards.
    3) NDA on track to be submitted in the 2nd half of 2015. NDA is complete, manufacturing quality systems on track.= SUBMITTED NDA TO FDA SEPT 3, 2015.
    3) 60 days for the FDA (Food and Drug Administration ) to accept the application by about Q1 2016.
    4) Upon potential acceptance, FDA could also grant priority review.
    5) With priority review, six months pdufa date (Prescription Drug User Fee Act ), without, 10 months. Best guess is July to Oct 2016.
    6) EU ( European Union ) filing 6- 9 months post FDA filing. Perhaps Q2-3 2016. Large unmet need in EU.
    7) ADP enrollment (019 study) complete by 2015 Q4 and data by about Q2 2016
    8) Schizophrenia maintenance trial to commence 2nd half of 2015.
    9) Sleep Study to begin 2nd half of 2015.
    There are NO ongoing issues with the FDA.

  • Strong hands pick up the cheap shares due to unchanged AVXL fundamentals. I hope to gather a few shares myself tomorrow or Friday. I would be surprised if shorts hold it over the Labor Day Holiday.

  • Reply to

    OT - Four stocks will move up soon....

    by dnwang Sep 1, 2015 8:28 PM
    crecy_war_knight crecy_war_knight 21 hours ago Flag

    take your garbage and head for the dump.

  • Reply to

    TRV130 v. A2-73

    by bealwood813 Sep 2, 2015 3:54 PM
    crecy_war_knight crecy_war_knight Sep 2, 2015 5:33 PM Flag

    Yeah, it can come with one of those little umbrella.

AMGN
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