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Deckers Outdoor Corp. Message Board

reality90210 182 posts  |  Last Activity: Aug 21, 2014 3:56 PM Member since: Mar 13, 2011
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  • reality90210 by reality90210 May 26, 2014 10:23 AM Flag

    change COLON and DOT-
    httpCOLON//patftDOTusptoDOTgov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-adv.htm&r=1&f=G&l=50&d=PALL&S1=08729019&OS=PN/08729019&RS=PN/08729019

  • Reply to

    new patent for drug delivery

    by reality90210 May 26, 2014 10:23 AM
    reality90210 reality90210 May 26, 2014 10:45 AM Flag

    thanks thought yahoo was limiting url posts

  • reality90210 reality90210 May 28, 2014 12:15 PM Flag

    I am told you can't do that? Can someone please confirm?

  • 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.

  • 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

  • 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

  • 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.

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

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

  • 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

  • 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

  • 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 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

  • 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

    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

  • 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 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

  • 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.

  • 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

    ahhhmmmm

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

    Read between the lines...

  • 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 !

DECK
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