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Deckers Outdoor Corp. Message Board

reality90210 64 posts  |  Last Activity: Jul 10, 2014 9:27 PM Member since: Mar 13, 2011
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  • reality90210 by reality90210 Jun 30, 2014 8:50 AM Flag

    buy the dips, we know what this is really worth!!
    don't let the shorts steal your shares.

  • Reply to

    NBC NEWS

    by reality90210 Jun 28, 2014 12:20 AM
    reality90210 reality90210 Jun 28, 2014 1:02 AM Flag

    shameless bumping but what the hey,,,BUMP

  • Reply to

    NBC NEWS

    by reality90210 Jun 28, 2014 12:20 AM
    reality90210 reality90210 Jun 28, 2014 12:49 AM Flag

    and CBS news
    http://www.cbsnews.com/news/inhalable-insulin-for-diabetes-wins-fda-approval/
    and BLOOMBERG
    http://www.bloomberg.com/news/2014-06-27/mannkind-wins-u-s-fda-approval-for-inhaled-insulin.html

    and just hit the airwaves via Rueters in INDIA and AUSTRALIA

  • reality90210 by reality90210 Jun 28, 2014 12:20 AM Flag

    For those who REALLY don't know how big this is!

    do a you tube search for this jw_v7d_zoHc

  • reality90210 by reality90210 Jun 27, 2014 11:56 PM Flag

    Reading posts, enjoying and thanking Al Mann for his persistence... thank you Dr Mann,
    Not the least bit worried, we will see this stock reach 20s shortly. Not worried about partners, they will come without MNKD having to court them. Wondering what else Technosphere can be used for..
    Thanking the all true believers in the stock, the company and technology. Thank you, you know who you are.
    Message to diabetics: I hope this product eases your pain and suffering. No cure, but hopefully it helps you manage your condition more efficiently and effectively.
    Peace all.. I sleep well tonight!

  • reality90210 reality90210 Jun 27, 2014 5:29 PM Flag

    THANK YOU!

  • The really got taken out. I wish I was by a computer when I found out; would have bought MORE!
    By the way-- Here's an excerpt from FDA release:
    "The FDA is requiring the following post-marketing studies for Afrezza:

    a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;"

    Pediatric patients..
    MNKD to the MOON !

  • Reply to

    ahhhmmmm

    by reality90210 Jun 19, 2014 11:05 AM
    reality90210 reality90210 Jun 19, 2014 11:10 AM Flag

    Read between the lines...

  • reality90210 by reality90210 Jun 19, 2014 11:05 AM Flag

    Bloomberg---
    A day after Sanofi (SAN) announced a diabetes alliance with Medtronic Inc. (MDT), its research chief said the Paris-based drugmaker may seek other partnerships to expand in one of the fastest-growing medical conditions.

    “We are open-minded” on other possible partnerships or acquisitions in diabetes, said Elias Zerhouni, Sanofi’s head of research and development, in a telephone interview. “We want to absolutely excel in the injectable space and I think that’s what we are accomplishing, but that is still going to be half of the market. We will be opportunistic.”

    Sanofi, which makes the top-selling insulin Lantus, and Medtronic, the biggest maker of heart-rhythm devices, yesterday said they’ll work together to develop combinations of diabetes medicines and devices, and seek technology-based services to simplify insulin use and improve treatment compliance.

  • Reply to

    Quick Question

    by perrhann Jun 18, 2014 12:28 PM
    reality90210 reality90210 Jun 18, 2014 4:47 PM Flag

    ditto here. I do know that the FDA would have hell to pay if they don't approve the drug; and the only reason I see why they may not approve it would be political and the FDA reviewers being paid off by a competitor of MNKD.

  • Reply to

    Quick Question

    by perrhann Jun 18, 2014 12:28 PM
    reality90210 reality90210 Jun 18, 2014 3:18 PM Flag

    Correct and they had rejected it after the first adcom unanimously voted in favor of approval in 2008 when the drug was owned by Schering-Plough
    http://www.wnd.com/markets/news/read/4865853/fda_advisory_committee_unanimously_recommends_u.s._approval_of_sugammadex

  • reality90210 by reality90210 Jun 18, 2014 1:55 PM Flag

    Would love to get a daily eyewitness report on "any flurry of activity" at HQ..

  • Reply to

    Quick Question

    by perrhann Jun 18, 2014 12:28 PM
    reality90210 reality90210 Jun 18, 2014 1:48 PM Flag

    Want to stay real here.The FDA did reject Merck's sugammadex at least twice after an advisory committee unanimously approved the drug.
    http://www.fiercebiotech.com/story/merck-rd-hammered-another-setback-fda-rejects-anesthesia-drug/2013-09-23

    Doesn't mean MNKD will get rejected, but there is always a small chance

  • Reply to

    May well be a stroke of genius

    by matese16 Jun 13, 2014 12:15 PM
    reality90210 reality90210 Jun 13, 2014 12:20 PM Flag

    Agreed. I may not be investor in MNKD for a long time, but I have been buying. i also intend to stick it out a lot longer than 6-8 weeks. Simply because I believe that MNKD is about to revolutionize the inhalable drug market!!

  • Reply to

    New Job Description- Putting 2 and 2 together

    by reality90210 Jun 11, 2014 6:27 PM
    reality90210 reality90210 Jun 11, 2014 8:47 PM Flag

    no so the positions state experience with GMP regulations as a requirement. GMP regulations continue even after approval as an ongoing check; so I see them preparing for approval. Also it could be that the FDA advised them that they must have GMP compliance people on staff as a condition for approval (inspectors and regulators working with the company-- isn't that what they stated in the last meeting? - ) so hence they are moving forward and it could be that the FDA already inspected. That's my take

  • So some of the jobs require an understanding of GMP regulations.
    +
    Here's what the FDA describes what are GMP regulations:

    "Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations
    Introduction
    FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
    The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.
    FDA can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations. Failure to comply can also lead to a decision by FDA not to approve an application to market a drug."

    REPEAT: "The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP."

    ----
    Looks to me like the manufacturing facility was just inspected and the FDA wants to ensure MNKD follows GMP. Approval is a given!

  • Reply to

    New MNKD jobs posted today!

    by pietv Jun 11, 2014 4:31 PM
    reality90210 reality90210 Jun 11, 2014 5:12 PM Flag

    Can I ask if anyone know if these weekend positions are in addition to the weekday positions? and are the weekday positions also day and night shifts? If so then we have a 24/7/365 operation

  • 68.25M - Went up by 200K from last time, but what is significant is
    DAYS to cover - 6 instead of 11
    tomorrow we go UP

  • reality90210 by reality90210 Jun 9, 2014 7:02 AM Flag

    http://www.sansum.org/artificialpancreasvideo/

  • reality90210 by reality90210 Jun 5, 2014 8:07 AM Flag

    For all of us who hope to make a LOT of $$s on the approval of Afrezza, I offer a perspective I found at the ADA sight. I for one hope we do make a lot of $$s but more importantly I hope this offers a REAL solution and alternatives to diabetics--

    The great thing about Afrezza is NOT the delivery system (despite what the company seems to think). They are "burying the lead" as they say in the news business. We Type-1ers are used to syringes and that's the least of our worries. The real advantage, and it's a huge one everyone here seams to be ignoring, is the speed with which Afrezza kicks in. It's ULTRA rapid. Closest to a real pancreas's timing. If they want to succeed at marketing this product, they need to stress that over the inhaler aspect. Those of us who use pumps already bypass needles for the most part but it still takes 15-30 minutes for our insulin to work.

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