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Deckers Outdoor Corp. Message Board

reality90210 189 posts  |  Last Activity: 21 hours ago Member since: Mar 13, 2011
  • 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.

  • Reply to

    YMB Bashing post timing

    by ricemba1965 May 30, 2014 11:53 AM
    reality90210 reality90210 May 30, 2014 12:09 PM Flag

    certainly scare tactics being utilized. It is fun to watch it go up and then go right down in mere seconds, but what they are doing is taking out trailing stop loss percentages. Don't be fooled

  • Reply to

    Today We Close between $9.00 and $9.10 - Trust Me

    by hawaiiguy42 May 29, 2014 11:18 AM
    reality90210 reality90210 May 29, 2014 11:26 AM Flag

    Hey I liked your call yesterday. You were dead on.
    Bump

  • reality90210 reality90210 May 28, 2014 12:55 PM Flag

    great thank you!
    I just placed a limit order from my cash account so that they can't be lent. If they want them they can have them for $19 each.

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