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Steven Madden, Ltd. Message Board

shorthound 115 posts  |  Last Activity: Aug 26, 2015 4:06 PM Member since: Jul 21, 2000
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  • Reply to

    Potential bonanza...

    by livinginlascolinas Aug 26, 2015 2:21 PM
    shorthound shorthound Aug 26, 2015 4:06 PM Flag

    Funny, but I think it might do slightly better than that.

  • Reply to

    FDA should be getting close to a decision

    by feoli2003 Aug 24, 2015 11:43 AM
    shorthound shorthound Aug 25, 2015 10:49 PM Flag

    these were posted by other users...

    you comment about info being suppressed is interesting....in the book The China Study, top cardiologists admitted they didn't want people to know what foods were best to eat to prevent heart disease because the doctors might lose business

    FDA = Corrupt ... My wife's natural thyroid medicine was just taken off the shelf because even though it has been used for 100 years with no ill effects, it now needs to go through their process. Except who will pay for it? No one... oh and by the way, there is a synthetic version which the drug companies have... - ,

  • Reply to

    FDA should be getting close to a decision

    by feoli2003 Aug 24, 2015 11:43 AM
    shorthound shorthound Aug 25, 2015 10:15 PM Flag

    "Goes to show who FDA really works for!" funny you should post that Feoli

    Came across this a few years ago on a trading site I was on from an anonymous poster...

    It is the drug companies who control significant funding of the FDA... The FDA needs to protect the profits of the drug companies to insure their own funding... It is the FDA that actively suppresses information of safe low cost alternatives to expensive drugs... They actually make it illegal to spread the word about these... The Drug companies suppress bad PR and alternatives by controlling advertising dollars in the media... The media companies can't afford to #$%$ off their customers (yes the advertisers are the customers, not the viewers)... The drug companies control information by writing the textbook curriculum for the medical students... The drug companies control the direction of research with grants to colleges... The drug companies control legislation with Washington lobbyists and campaign contributions...Conflicts of interest have hit a new high!

  • shorthound shorthound Aug 19, 2015 12:48 AM Flag

    Interesting, seems like OVAS is in the same boat as IVOB, currently not avail in US.

    This website contains information about the AUGMENTSM treatment, which is available in certain IVF clinics in select international countries. The AUGMENT treatment is not available in the United States.

  • Reply to

    ASRM Conference this Fall

    by feoli2003 Aug 18, 2015 10:08 AM
    shorthound shorthound Aug 18, 2015 10:00 PM Flag

    money_hungry,

    This is the conference where two very important presentations were given last year highlighting the results of the INVOcell and where the ASRM body basically "endorsed" the product and procedure as providing a huge benefit by significantly reducing the costs for IVF.

    If you look back in the Oct/Nov timeframe you will see various articles on the subject and information on the presentations as well. One was given by Dr Kevin Doody from the CARE Fertility Center in Bedford Texas which conducted a trial in conjunction w/ Invaron from Canada. The other was given by the Cecolfes center in Columbia.

  • Reply to

    should be at .60c now

    by yesssmommm Aug 17, 2015 11:53 AM
    shorthound shorthound Aug 18, 2015 1:48 AM Flag

    or they just keep inundating them with additional questions and so on and so on and so on

  • Reply to

    FDA faster approval times

    by shorthound Aug 14, 2015 8:02 PM
    shorthound shorthound Aug 14, 2015 10:28 PM Flag

    Here are some highlights from the report. All data is current as of March 31, 2015.

    - 510(k) decision times for low- or moderate-risk devices decreased from an average of 132 days in FY 2010 to about 115 days in FY 2014.
    - PMA decision times for high-risk devices decreased from an average of 352 days in FY2009 to 242 days in FY 2014.
    - IDE decision times permitting use of a device in premarket trials fell from a whopping 442 days in FY 2011 to 30 days in FY 2015.

    And the agency touted several new regulatory initiatives such as:

    - Moves to streamline the clinical trial process, including a guidance document encouraging the use of flexible adaptive clinical trial designs
    - A shift in its benefit-risk analysis that includes differing collection of some data to postmarket settings so that commercialize can commence at an earlier data. There is a guidance document on this issue as well.
    - Initiatives to collect more information about patient preference data. This kind of information informed the FDA's decision to approve its device to treat obesity since 2007.
    - And finally, the launch of the Expedited Access Pathway Program to speed up approval of selected "breakthrough devices."

  • Reply to

    FDA faster approval times

    by shorthound Aug 14, 2015 8:02 PM
    shorthound shorthound Aug 14, 2015 10:18 PM Flag

    Here is a recent story on the FDA and their improved review process...

    FDA touts faster approval times in report on initiatives at its device arm

    By Varun Saxena

    The FDA touted faster approval times in a report on policies and initiatives at its device arm (CDRH). In addition, the agency outlined some of its new regulatory initiatives.

    Overall, industry says the device arm has made progress over the past 5 years, prior to which complaints about the lack of regulatory clarity were more common. Steps to increase the speed of decision-making and improve the clinical trial paradigm appear to be helping, based on moves like the faster-than-expected approval of next-generation TAVRs made by Medtronic ($MDT) and Edwards Lifesciences ($EW). And the report's statistics show the FDA is making progress

    Still, devices of all sorts are regularly approved in Europe years before they are permitted for commercialization in the U.S., so the FDA still has work do to meet CDRH head Dr. Jeffrey Shuren's vision of U.S. patients "having access to high-quality, safe, and effective medical devices of public health importance first in the world."

    But the agency is getting pulled in opposite directions. One recent study by Harvard Business School blamed the FDA's regulation and procedures for the delay, while another in the Journal of the American Medical Association said more evidence of safety and effectiveness is needed.

    The FDA is trying to beef up its postmarket monitoring and regulation of devices, and industry hopes it will grant device companies faster approvals and cut back on premarket regulations as a tradeoff.

    The report takes on added importance because Congress is considering a pro-industry overhaul of the device (and pharma) industry via the 21st Century Cures Act. It has passed the House of Representatives but has not yet received a vote in the Senate.

  • Reply to

    FDA faster approval times

    by shorthound Aug 14, 2015 8:02 PM
    shorthound shorthound Aug 14, 2015 8:16 PM Flag

    Here are some highlights from the report. All data is current as of March 31, 2015.

    - 510(k) decision times for low- or moderate-risk devices decreased from an average of 132 days in FY 2010 to about 115 days in FY 2014.
    - PMA decision times for high-risk devices decreased from an average of 352 days in FY2009 to 242 days in FY 2014.
    - IDE decision times permitting use of a device in premarket trials fell from a whopping 442 days in FY 2011 to 30 days in FY 2015.

    And the agency touted several new regulatory initiatives such as:

    - Moves to streamline the clinical trial process, including a guidance document encouraging the use of flexible adaptive clinical trial designs
    - A shift in its benefit-risk analysis that includes differing collection of some data to postmarket settings so that commercialize can commence at an earlier data. There is a guidance document on this issue as well.
    - Initiatives to collect more information about patient preference data. This kind of information informed the FDA's decision to approve its device to treat obesity since 2007.
    - And finally, the launch of the Expedited Access Pathway Program to speed up approval of selected "breakthrough devices."

  • Well, we know when it comes to the FDA review of the INVOcell the process has faced delay after delay.

    I had seen something to the effect that the FDA was "improving" this process but of course I didn't believe it nor was I going to hold my breath.

    I'm sure many were expecting another 2-3 month wait before we heard back from the FDA on the most recent exchange with INVO Bioscience but it was nice to hear that the FDA had already communicated back and the company had responded as well. Things may be looking up.

  • Reply to

    IVOB vs AQXP

    by sewer182 Aug 12, 2015 3:35 PM
    shorthound shorthound Aug 12, 2015 6:08 PM Flag

    Another thing to consider, IVOB is a penny stock company that is several years behind in reporting vs AQXP is NASDAQ listed and according to Yahoo has a very small 4.5m share float.

  • Reply to

    IVOB vs AQXP

    by sewer182 Aug 12, 2015 3:35 PM
    shorthound shorthound Aug 12, 2015 5:02 PM Flag

    unfortunately its back down to $17 which leaves alot of bagholders

  • Reply to

    Maybe.

    by sewer182 Aug 12, 2015 1:26 PM
    shorthound shorthound Aug 12, 2015 4:25 PM Flag

    AQXP also came back down to earth...

  • shorthound shorthound Aug 12, 2015 4:15 PM Flag

    up to $50 down to $17, that's alot of new bagholders.

    it appears JNJ was a seller of over 1.5m shares, for you buyout dreamers, that gives JNJ a nice supply of fresh cash to put to work...hmmm

  • Reply to

    Scary.

    by money_hungry21 Aug 4, 2015 10:15 AM
    shorthound shorthound Aug 5, 2015 7:51 PM Flag

    money_hungry,

    if holding the position is causing you angst, sell half to cover your costs and let the rest run.

  • Reply to

    Scary.

    by money_hungry21 Aug 4, 2015 10:15 AM
    shorthound shorthound Aug 4, 2015 8:27 PM Flag

    true, there were many times over the years that this stock didn't trade a single share and no news.

  • Reply to

    PRODUCTiON

    by mriucd Jul 29, 2015 9:23 AM
    shorthound shorthound Jul 31, 2015 10:00 PM Flag

    So why don't you guys call them up and place an order. really it's the only way for you to evaluate the product and verify that it exists

  • Reply to

    Volume will have to start picking up anyday

    by feoli2003 Jul 31, 2015 9:48 AM
    shorthound shorthound Jul 31, 2015 7:15 PM Flag

    in a perfect world buddy, but these continual delays just prove there are outside forces at work.

    "At this rate this could go on for years"....are you new?

    What do you think has been going on since 2010-2012 ???

  • Reply to

    Volume will have to start picking up anyday

    by feoli2003 Jul 31, 2015 9:48 AM
    shorthound shorthound Jul 31, 2015 7:09 PM Flag

    Feoli, they've already said they are not going to do that *UNTIL* they have clearance. It just doesn't make any sense to put out the effort and $$$ until they get the FDA Golden Ticket.

  • shorthound by shorthound Jul 31, 2015 5:42 AM Flag

    So did anyone review results / conf call?

    Recvd notice that deposit reqs are going up for analysis accounts.

    Is this how they show increases in deposits...by extorting their banking clients?

SHOO
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