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Amicus Therapeutics, Inc. (FOLD) Message Board

fenix1357 66 posts  |  Last Activity: Nov 26, 2014 1:13 PM Member since: May 28, 2010
  • Reply to

    Whynotnymox: Placebo vs NX-1207

    by munkus16 Nov 25, 2014 6:50 AM
    fenix1357 fenix1357 Nov 26, 2014 1:13 PM Flag

    Antibiotic was given for three days and data was not collected until 90, 180, 270 days later. IMHO this antibiotic thing is not a big deal. All injectable placebos have big effects especially as I am sure there were cognitively challenged patients ( Recruiting was hard and I am sure no attempt was made to screen out people with alzheimers or other cognitive biases.). Having an injection and then seeing blood in your urine would convince them they had the actual drug.
    Agree Recordati has been recruiting for a year and there should be enough data for an interim analyses; certainly warranted. Also needed is for Dr. A to reveal all data, this paranoia is nonsense!
    I do think there was a signal for efficacy in the data if the drug was superior to placebo at all points in time and if Recordati interim analysis is positive grounds for a redesigned study. Also need some professional statisticians to look at the data and go over how it was collected and analysed and see if there are enough grounds to throw out the outliers in the placebo group.

    Dr. A do the job or step down.

  • Reply to

    Whynotnymox: Placebo vs NX-1207

    by munkus16 Nov 25, 2014 6:50 AM
    fenix1357 fenix1357 Nov 26, 2014 10:43 AM Flag

    I believe all patients were given antibiotics for three days or doses (I am not sure) orally as all of them (including the placebo patients) received an intraprostatic injection and hence were at risk of infection. I do not think three doses of oral antibiotics would cure prostatis (it takes weeks of antibiotics). Remember FDA approved the protocol.

  • Reply to

    sell or hold?

    by brokenrecordat895 Nov 22, 2014 9:16 PM
    fenix1357 fenix1357 Nov 25, 2014 1:53 PM Flag

    There are positives and negatives to holding.
    The positives are their financing agreement is holding so money is not a problem and so no reverse splits and dilution. The selling also seems to have abated and this seems to be the bottom price.
    Other positives are that the BPH trial in Europe is still going on and looks it will be completed. Since the drug was effective but failed to show statistical significance against the placebo and this placebo is different (not as powerful as historically injectable placebos are more powerful), there is a fair chance this study will be positive. Based on this study if positive they can hope to get EU approval and also possibly sell it in Asia/Africa and USSR. Also they can elect to do a small trial in US with run in to minimize the placebo effect (if they have the financing). This trial will have small numbers and hopefully only be for six months as the drug can get approved on a six month study .
    Another positive is the cancer indication. Its hard to be sure because they do not release any topline data but if they proceed with another trial for this or get some collaboration it will be an indication (hopefully ) that the numbers were meaningful in the first trial. I suspect LG will also demand more accountability after this current fiasco.

    The negatives are Dr. A and Dr. A and Dr.A. He has not conducted himself as a proper CEO. Just a shell shocking announcement with no further conference calls to explain further measures the company is taking to boost shareholder value. His paranoia and secrecy with no release of details is harming the company.

    There, you have my two bits :)

  • Reply to

    NX-1207 and BPH vs PC.......a question:

    by munkus16 Nov 21, 2014 2:03 PM
    fenix1357 fenix1357 Nov 22, 2014 9:57 PM Flag

    I meant posts not E mails, apologise for the error.

  • Reply to

    NX-1207 and BPH vs PC.......a question:

    by munkus16 Nov 21, 2014 2:03 PM
    fenix1357 fenix1357 Nov 22, 2014 9:52 PM Flag

    I was responding to why not.Your opinions dont matter to me.

  • Reply to

    NX-1207 and BPH vs PC.......a question:

    by munkus16 Nov 21, 2014 2:03 PM
    fenix1357 fenix1357 Nov 22, 2014 2:16 PM Flag

    Don't abuse him; feel sorry for him. He only gets off by taking delight in making other people miserable. An example of a person who is an abject failure at being a human being.

  • Reply to

    NX-1207 and BPH vs PC.......a question:

    by munkus16 Nov 21, 2014 2:03 PM
    fenix1357 fenix1357 Nov 22, 2014 2:12 PM Flag

    I guess you are a retired doctor and afraid to debate someone with more recent knowledge. I see you never respond to my E mails challenging your assumptions. I have already presented stats to you that 90% of the patients for watchful waiting elect to have a treatment- RT or surgery. In this case this offers a way of avoiding the morbidity (not mortality ). Kaplan Meier is not necessary.

  • Reply to

    Recordati has published a new presentation:

    by dupuismich Nov 20, 2014 5:51 PM
    fenix1357 fenix1357 Nov 20, 2014 6:34 PM Flag

    Nothing new on NX1207 unfortunately, still talks about it being in phase three trials.

  • Reply to

    Recordati

    by whynotnymox Nov 18, 2014 1:56 PM
    fenix1357 fenix1357 Nov 20, 2014 1:25 PM Flag

    Dr. Shore has had no association with NYMOX for the last few years. He is touting another co. now. See my previous post from a few months back below.

    The reason he said this was because he is now touting an alternative BPH treatment (See below) which does not involve needles.. He is a paid consultant; he endorses whatever procedure he is currently performing. I am glad he did not put down NX 1207 for any other reason. Your honesty is appreciated. Thanks.

    Click here for an article on sexual function and BPH by Neal D. Shore, MD, Myrtle Beach, South Carolina. Dr. Shore is a clinical urologist and principle investigator of the Prolieve Thermodilatation® System, who specializes in prostate disease and has performed more than 200 office-based minimally invasive treatments for the symptoms of BPH. This article is based on Dr. Shore's clinical experiences and opinions. Dr. Shore is a paid consultant of Boston Scientific.

  • Reply to

    Recordati

    by whynotnymox Nov 18, 2014 1:56 PM
    fenix1357 fenix1357 Nov 20, 2014 11:51 AM Flag

    Usually when I am long a stock I pay more attention to the posters who are short as it is a good way to question your assumptions and see if you are wrong but on thus board I have decided to put wrb, munkus and howabout on ignore. They are the same person with the same uninspiring intellect and paranoid fantasies and contribute nothing to my understanding.

    A basic statistical primer-If you toss a coin 4 times and it comes up heads all 4 times, the odds of doing that are one in sixteen or around.0625. This implies the odds that the coin is biased in some way is pretty high. In clinical trails we put significance at .05 so if the drug was higher than placebo at all 4 points there is a good possibility it works. Proven beyond doubt -no but good possibility-yes.

    As to all the paranoid fantasies its worth pointing out the person who has lost the most is Dr.A; he now owns 1/3 of a co. which is worth 18 million now and before was worth 200 million. Do the maths.

  • Reply to

    Recordati

    by whynotnymox Nov 18, 2014 1:56 PM
    fenix1357 fenix1357 Nov 18, 2014 10:54 PM Flag

    I emailed them twice (Recordati) and got a prompt response each time (unlike Nymox which still has not responded to my E mail from two weeks ago).
    They still have not received the data from NYMOX and the trial will continue until they can review the data. They have no anticipated date by which they will receive the data.

    Reading between the lines it appears the bulk of the money has been spent so they would rather continue the trial as if successful they can get EU approval based just on this trial. The chances of this trial succeeding are greater because its a single blinded trail which historically has a less placebo effect than a double blinded trail which was the case with the US trials.

    The NYMOX trials as per the conference call showed better results with the drug than placebo at all points 90,180,270 and 365 days although not statistically significant. This is good presumptive evidence of statistical significance. If you toss a coin 4 times, the chances of it coming up heads all four times in only 0.0625 a fairly low probability number. This seems to suggest the drug works and a better designed trial could succeed.

  • Reply to

    Recordati

    by whynotnymox Nov 18, 2014 1:56 PM
    fenix1357 fenix1357 Nov 18, 2014 6:36 PM Flag

    I emailed them twice (Recordati) and got a prompt response each time (unlike Nymox which still has not responded to my E mail from two weeks ago).
    They still have not received the data from NYMOX and the trial will continue until they can review the data. They have no anticipated date by which they will receive the data.

    Reading between the lines it appears the bulk of the money has been spent so they would rather continue the trial as if successful they can get EU approval based just on this trial. The chances of this trial succeeding are greater because its a single blinded trail which historically has a less placebo effect than a double blinded trail which was the case with the US trials.

    The NYMOX trials as per the conference call showed better results with the drug than placebo at all points 90,180,270 and 365 days although not statistically significant. This is good presumptive evidence of statistical significance. If you toss a coin 4 times, the chances of it coming up heads all four times in only 0.0625 a fairly low probability number. This seems to suggest the drug works and a better designed trial could succeed.

  • Reply to

    Pitiful -

    by stock1trader1a1 Nov 15, 2014 6:06 AM
    fenix1357 fenix1357 Nov 17, 2014 9:05 AM Flag

    You guys are the ones doing all the end zone dancing. WRB even has a new moniker to pat himself on the back because no one else will.

  • Reply to

    WRB, no one has posted this

    by fud_wrecker Nov 15, 2014 1:05 PM
    fenix1357 fenix1357 Nov 16, 2014 7:50 PM Flag

    You are pathetic WRB. Your third new minker after wrb,monkeyfuss16 and now lifewrecker. You lost money on your October puts and Noevember calls..Tota lloser!

  • Reply to

    Pitiful -

    by stock1trader1a1 Nov 15, 2014 6:06 AM
    fenix1357 fenix1357 Nov 16, 2014 4:18 PM Flag

    I was not going to post here again but with all the misinformation posted by how howabout gas bag, wrb and monkeyfuss I felt I had to.
    Let me explain to you why the $100,000 was raised. It was to demonstrate that their long term funding agreement with LG is intact and this could be put in the 6K. Notice the 6K does not have a "going concern" statement by the auditor and this $100,000 draw is the reason why. This is why the stock went up when the 6K was released and will hopefully go up some more so no dilution or reverse split will be needed.
    This is dead money for a while but as I said in my previous post but should go up in 2016.

  • Reply to

    THE DRUG WORKED

    by longmox Nov 6, 2014 9:37 AM
    fenix1357 fenix1357 Nov 10, 2014 8:54 AM Flag

    Sorry my mistake! 400 placebo patients to drop a point is 400 points ie 16 placebo patients who responded with improvements of 25 points.

  • Reply to

    THE DRUG WORKED

    by longmox Nov 6, 2014 9:37 AM
    fenix1357 fenix1357 Nov 8, 2014 8:54 AM Flag

    Look at this way. To gain an additional1 point to make the data staistically meaningfull you need to subtract a 1000 points from the placebo in aggregrate. If you have 40 placebo patients reporting a 25 point improvement that is one possible source. You mean to say in the 400 placebo there were no cognitively challenged patients over 80 who were suggestible.

  • Reply to

    YES WE DESERVE BETTER

    by boubalouyu Nov 7, 2014 6:08 PM
    fenix1357 fenix1357 Nov 8, 2014 8:42 AM Flag

    I am going to stop posting here because I see no value in posting but here are a few of my observations FWIW.

    Dr. A sold to protect himself, every CEO does that before pivotal results come out. I dont like the mans paranoia but I do not think he is a cheat.

    The BPH indication is dormantfor a while till a detailed analysis is done unless a possible flagrant error is found. It will most likely need another trial of around 100-200 patients where the placebo response is closely monitored by trained individuals; see the ACAD last trial for how they overcome exactly the same problem.

    The prostate cancer indication is promising and from the CC he seems to think it will take two years and 6 million dollars which he thinks is doable. There will be no dilution , LG will provide the finnacing through the finnacing vehicle. They have already pumped over 125 million in this co.; another 6 million in the hope of recouping the money will be no issue for them.

    LG will support the price over 1 dollar if neeeded. Once they anounce the prostate trial that should help.

    This is dead money for a while but the SP will cross 6 dollars in 2016.

    GoodLuck!

    Fenix

  • Reply to

    THE DRUG WORKED

    by longmox Nov 6, 2014 9:37 AM
    fenix1357 fenix1357 Nov 7, 2014 1:36 PM Flag

    They never give a link to the conference call. I have an app on my cellphone which records all conversations.
    Dr. A claimed to have received the data at the end of last week and rushed to give investors the good news so he is not accused of insider trading. He is going to look at the data now.

  • Reply to

    We deserve better

    by whynotnymox Nov 7, 2014 9:03 AM
    fenix1357 fenix1357 Nov 7, 2014 12:00 PM Flag

    Good advice. I will start with an E mail.
    The conference call was surreal. I intend to get to the bottom this even if I have to spend some cash. I want the topline numbers both for this and the prostate cancer trial and feel I am entitled to it.

FOLD
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