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Amicus Therapeutics, Inc. (FOLD) Message Board

fenix1357 38 posts  |  Last Activity: Apr 9, 2014 10:57 AM Member since: May 28, 2010
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  • Reply to

    prozac

    by whynotnymox Apr 8, 2014 10:55 PM
    fenix1357 fenix1357 Apr 9, 2014 10:57 AM Flag

    Those days are long gone. Newly discovered biologics are being approved regularly. Recently FDA came out a with a statement on how it wants to expedite review of new biologics. The times are changing; the only thing that never changes is NYMX and Dr A. with constant paranoia, obfuscation and out right lies and blatant disregard of shareholder rights.

  • Reply to

    End of quarter approaching

    by longmox Mar 28, 2014 12:37 PM
    fenix1357 fenix1357 Mar 28, 2014 1:40 PM Flag

    There is no one here except for Dr. As brain dead love birds and computer bots. Welcome back to the land of living dead!

  • fenix1357 fenix1357 Mar 23, 2014 6:25 PM Flag

    Assuming even if that is the case that does not explain the delay. If what you are saying is true DMC would grant a continue and recommend more trial subjects be recruited. It does not explain the delay unless you think NWBO is hiding the news.

  • Reply to

    Nymox is a public company subject to

    by animalkrakers Mar 19, 2014 10:33 AM
    fenix1357 fenix1357 Mar 19, 2014 11:11 AM Flag

    Welcome back #$%$ eraser!

  • Reply to

    GOOD news for all!!!

    by how_bout_we_talk Mar 18, 2014 1:42 PM
    fenix1357 fenix1357 Mar 19, 2014 10:11 AM Flag

    Good Luck! I agree the company is not run professionally but hopefully this is more a function of Dr. A's personality rather than a problem with the drug.

  • fenix1357 by fenix1357 Mar 12, 2014 1:53 PM Flag

    In the conference call they stated they might not have to recruit 338 patients that it was events driven. Anybody with more statistical knowledge care to speculate as to how many additional patients they will have to implant; assuming similar results as in the past.

  • Reply to

    Why this explosion of hostility

    by greenberg_avi Mar 12, 2014 12:20 PM
    fenix1357 fenix1357 Mar 12, 2014 1:43 PM Flag

    I do not believe this as long a shot as you think. It has worked in both prostate and liver cancer (admittedly only in animal models and the petri dish). I would think the chances are fair that its effective or worst case scenario has no effect.

  • fenix1357 fenix1357 Feb 25, 2014 8:55 AM Flag

    Charles Schwab is at 100%

  • Reply to

    A.P.Increase position

    by boubalouyu Feb 18, 2014 12:04 PM
    fenix1357 fenix1357 Feb 24, 2014 11:46 AM Flag

    Thanks. NWBO at 6.8 today!

  • Reply to

    A.P.Increase position

    by boubalouyu Feb 18, 2014 12:04 PM
    fenix1357 fenix1357 Feb 18, 2014 3:58 PM Flag

    All he has to do is sell shares make money and award himself more options and control more of the company. Are you and Bou paid by the company or just plain ignorant?

  • Reply to

    A.P.Increase position

    by boubalouyu Feb 18, 2014 12:04 PM
    fenix1357 fenix1357 Feb 18, 2014 3:30 PM Flag

    Correction to above post, should be 10000.

  • Reply to

    A.P.Increase position

    by boubalouyu Feb 18, 2014 12:04 PM
    fenix1357 fenix1357 Feb 18, 2014 3:06 PM Flag

    Kicking myself. I sold 10,1000 of NWBO in December at 3.8 to buy some more NYMX #$%$ as I thought the results would be out in Jan 2014. Guess what NWBO is now at 5.8 same price as NYMX.

  • Reply to

    DCVAX-Direct clinical trial design discussion

    by bballgm Feb 14, 2014 4:10 AM
    fenix1357 fenix1357 Feb 16, 2014 4:39 PM Flag

    The submission will not talk about the results at all. If you look at ASCO criteria they don't want results from incomplete trials. The way this is usually done is the submission will be about a new approach to treating inoperable cancer and will focus on the technicals of the process. The positive incomplete results will be announced separately and not at ASCO but everyone will be aware of them. Linda hinted as much when she stated there was a possibility that some results could be released at the same presentation she announced the ASCO effort.

  • Reply to

    Subgroups & DCVax - Trial durability

    by j.brantz2 Feb 13, 2014 2:44 PM
    fenix1357 fenix1357 Feb 14, 2014 5:37 PM Flag

    Do you even read what you write?
    You wrote a quote which supposedly is from the FDA telling the industry the DMC has no role in addressing unexpected issues but can help implement changes. Where does it say the DMC will decide to change the no. of of trial participants for statistical significance. Its talking about unexpected issues , changes for which are implemented with the help of the DMC.
    In my experience people insulting other people on anonymous message boards are usually stupid and cowardly, particularly if they gives themselves grandiose names and do not know how to decipher common vernacular.

  • Reply to

    Subgroups & DCVax - Trial durability

    by j.brantz2 Feb 13, 2014 2:44 PM
    fenix1357 fenix1357 Feb 14, 2014 2:28 PM Flag

    My reply was to rational disputing his conjecture about the DMC.

  • Reply to

    Subgroups & DCVax - Trial durability

    by j.brantz2 Feb 13, 2014 2:44 PM
    fenix1357 fenix1357 Feb 14, 2014 2:00 PM Flag

    You are wrong about the DMC. It has no role in suggesting trial modification. They are there for the safety of patients. They stop trials for futility or dangerous side effects or for good results so placebo patients can cross over and benefit or recommend the trial goes on. The fact that its taking so long can be meaningless or taken as a minor positive.
    I would be very curious to find the source of your assertion about the pathology of the P1 trial patients.

  • Reply to

    New CFO hire - significant upgrade

    by johncoctostan2014 Feb 5, 2014 3:04 PM
    fenix1357 fenix1357 Feb 6, 2014 8:57 AM Flag

    It cuts both ways. Agreed the new CFO would require a more lucrative deal but Dr. A would only do it if it was needed such as negotiating a deal. We also don't know the terms of Mr. Wolvins departure, if he is allowed to keep his options etc.

  • •TFDA General

    FDA Mulls Faster OK for High-Need Devices
    1/31/2014

    WASHINGTON -- The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals.

    The change the agency is considering would create more post-approval studies for products and bring more uncertain devices to the marketplace, Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health in Silver Spring, Md., said Thursday.

    Shuren expressed concern that U.S. patients are increasingly waiting longer to gain access to certain devices because of burdens the FDA places on companies. He was speaking at an event hosted by the Pew Charitable Trusts, a nonprofit that lists one of its missions as making sure patients have timely access to safe and effective devices.

    "We ensure devices are safe and effective, and that's protecting public health," Shuren said. "But we also have to promote public health, ensuring that there's timely access to those technologies, and facilitating innovation."

    Shuren said makers of cardiac devices are starting to turn to countries outside of the U.S. and Europe to launch their products because of the barriers the FDA and other regulators have placed on approvals.

    "A safe and effective technology may take longer to get to U.S. patients, and that's contrary to what we are about," he said.

    The answer, he continued, is to turn to post-approval studies. While the FDA currently has tools to speed devices to market or require post-approval studies, each has shortcomings, Shuren said.

    For example, the FDA can require post-approval studies for devices approved under the pre-market approval application process. However, the standard for approval is still a high bar to manufacturers and may not be quick for products with a high need.

    Post-approval studies are harder for the FDA to require for its de novo classification process, which is an ex

  • Reply to

    Fork in the Road

    by fenix1357 Feb 1, 2014 6:38 PM
    fenix1357 fenix1357 Feb 1, 2014 6:44 PM Flag

    I fully realize that results in labs and animals do not equate to results in humans but their prior results for trials/experiments with carcinoma cell lines do seem to indicate that NX1207 might work against localized cancer, prostatic and even liver. There is a decent chance that their phase two trial might be successful and proceed onto a phase three trial. The phase three trial might or might not work but the results of the phase two will provide a ( temporary?) boost to the share price.

    These are my reasons for staying in the stock. Meaningful comments solicited.

  • fenix1357 by fenix1357 Feb 1, 2014 6:38 PM Flag

    With all that has happened recently I sat down and thought hard about this stock and I decided to stay the course for the following reasons.

    First of I categorically do not trust the company and Dr.A. I think its a second rate company by any standard but unless you discount the results of all the trials that were performed in multiple centers I think they are on to something with NX1207.
    If the results are what they are (I ran some statistical studies with their various result iterations )and although the analysis is not exactly scientific they are likely to come up with very similar results to their phase two studies with improvement in AUA score of 8-10 and increase in Qmax of around 2.6. While on this subject although we think of improvement in AUA scores as the most important criteria it is not necessarily the most important criteria. In most BPH studies even placebo gets an improvement of around 6 so 8-10 is not magical and will be roughly in the same ballpark as Flomax. In fact there was a recent letter by the FDA to the company that manufactures Flomax warning against its consumer advertisements which claimed that Flomax was the best drug in its class because of the AUA scores. The FDA letter went on to state that there was no evidence that improvement in AUA scores equated to increased patient comfort and there was no evidence that Flomax was best in class. The letter can be googled by the way.
    If AUA is subjective then the best objective indicator is an improvement in Qmax and in this category NX1207 shines. Flomax gets an average improvement of 1.5ml/sec and NX1207 gets an improvement of around 2.6ml/sec. Even the Sophiris product does not get such an improvement in the Qmax with similar/ lesser improvements in the AUA score.
    CONTINUED

FOLD
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