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Yongye International, Inc. Message Board

wtd1776 11 posts  |  Last Activity: Apr 2, 2014 9:29 PM Member since: Apr 28, 2010
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  • Reply to

    Congrats to Al Mann and All Diabetics

    by afrezzauser Apr 2, 2014 8:48 PM
    wtd1776 wtd1776 Apr 2, 2014 9:29 PM Flag

    afrezzauser, are any of the clinical trial participants going to go to the PDUFA meeting on the 15th? Or are they even allowed? If yo know. Thanks for you participation and obvious help.

    Sentiment: Strong Buy

  • Reply to

    FDA docs

    by koolbrez22 Mar 29, 2014 5:13 PM
    wtd1776 wtd1776 Mar 29, 2014 5:37 PM Flag

    Go to FDA.gov and search Mannkind Corporation, then select the link in the list
    [PDF]AFREZZA® (insulin human [rDNA origin]) Inhalation Powder ... [Advisory Committees]
    click the link
    FDA Briefing Information for the April 1, 2014 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 9.6MB)1

    That will be the document that you are looking for.

  • I have tried to post the link to the FDA document, but Yahoo won't let the link be posted. It was amazing to me when reading Exubra's FDA document that it was actually worse than what has been presented for Afressa.

    This PDF document describes all of the concerns about EXUBRA, and they approved it..... The brief can be found at the FDA website - 2005/4159B1_02_07-FDA-Clin_Efficacy

    Sentiment: Strong Buy

  • Reply to

    So far two yes and rest NO!

    by rvga128 Jan 23, 2014 7:15 AM
    wtd1776 wtd1776 Mar 9, 2014 5:13 PM Flag

    RXR, you were a jerk last year and you're still a jerk. Not a single thing your claimed last year turned out to be true, and now you're back spouting the same garbage claiming it to be true. The issue at hand is due to a ligit vote by stockholders and has absolutely nothing to do with a YONG conspiracy. Get a real job You're showing your ignorance!

    I ignored your last year and made 10's of thousands of dollars profit in YONG. I sold at over $6.00 when you were projecting a complete bankrupt company. Go away before you hurt some weak handed investors, like you did last year, that don't have the fortitude to hang on.

  • This was interesting reading. They had nothing but good things to say about ORIG as compared to their closest competitors. I am hoping to see some positive movement in this thing over the next few weeks. I don't understand why it hasn't moved up yet. They have beat the estimates for the past 5 qtrs. and are proported to start paying a dividend in the next qtr. I expect to see this priced in the low $20's real soon.....

    Sentiment: Strong Buy

  • I received a photo complements of Doyon Insurance in Danbury, CT showing Mannkind's parking lot last monday 2/3/14. The lot is full, so they are pretty busy doing something. I would post the picture if I knew how.

    Sentiment: Buy

  • Guidance for the Public and FDA Staff on
    Convening Advisory Committee Meetings

    Considerations when to Convene a Meeting

    In those instances in which FDA is not legally compelled to refer a matter to an advisory
    committee, it may nevertheless choose to do so voluntarily. When considering whether
    to convene such a meeting, FDA should consider the following three factors:

    (a) Is the matter at issue of such significant public interest that it would be highly
    beneficial to obtain the advice of an advisory committee as part of the
    agency’s regulatory decision-making process?

    (b) Is the matter at issue so controversial that it would be highly beneficial to
    obtain the advice of an advisory committee as part of the agency’s regulatory
    decision-making process?

    (c) Is there a special type of expertise that an advisory committee could provide
    that is needed for the agency to fully consider a matter?

    In the event that one or more of these factors is met, the matter at issue should generally
    be referred to an advisory committee.

    FDA regulates a broad range of products and conduct, which means the preceding factors
    must be evaluated in many different contexts. To provide more clarity on when to hold
    meetings, the bullets below identify different kinds of scenarios in which one or more of
    the factors are often met.

    • FDA is evaluating a first-of-a-kind, first-in-class medical product for human use.

    • FDA is evaluating a medical product for a significant new indication.

    • FDA is evaluating a novel product or use of new technology.

    • FDA is evaluating a medical product that involves a significant diagnostic,
    therapeutic, or preventative advance.

    Essentially, the way I see it, the FDA was required to convene
    an "Advisory Committee Meeting". The fact that is will convene only two (2) weeks prior to
    the scheduled approval date indicates to me that it may just be a formality.

    lnk = fda.gov/downloads/RegulatoryInformation/Guidances/UCM125651.pdf

    Sentiment: Strong Buy

  • The fda removed restrictions on glaxosmithkline avandia today (monday) allowing them to sell it without restrictions placed on them back in 2010. the patent expired on avandia in 2011. they continued to sell it with restrictions placed on the patients to be enrolled in essentially a experiemental drug program.

    i don't believe this will have more than a temperary effect on ,mnkd. final fda approval announcement and the partnership agreement will send us on our way. we need to remember avandia was only for type 2 diabetics and afressa was being developed during avandia's time on the market, afrezza was ment to compete against avandia all along.

    Sentiment: Strong Buy

  • wtd1776 wtd1776 Oct 20, 2013 8:31 PM Flag

    Viorel263 where did you hear of this. I went onto the UHC site and could not find any notices. I searched for everything from NIPT to the policy number you quoted. Please advise.


    Sentiment: Buy

  • wtd1776 wtd1776 Oct 16, 2013 6:25 PM Flag

    You may want to look at PSEC for dividend and less risk of interest rate increasing. Pay about the same %dividend as NLY, but not so tied to FANNIE and FREDDIE.

    Sentiment: Buy

  • Yesterday (10/7/13) Mannkind listed eleven (11) new open positions in their Danbury Connecticut production facility that they are looking to fill.

    Below is the list of positions they are hiring for:

    Sr. Director – Technical Services
    Sr. Manager/Engineer – Automation & Control
    Production Supervisor – Fill/Pack
    Director – Supply Chain
    Sr. Specialist - Production Planner
    Equipment Engineer
    Process Engineer
    Calibration Coordinator
    Calibration Technician
    Quality Assurance Associates
    Manufacturing Operators

    Notice the last two (2) positions are for multiple associates. This move makes it obvious that they are gearing up for the launch! This may be the inflection point that all of us have been waiting for.

    Sentiment: Strong Buy

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