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Optimer Pharmaceuticals, AŞ Message Board

francolaval 22 posts  |  Last Activity: Aug 24, 2015 4:19 PM Member since: Mar 22, 2002
  • Booster regimen, Her 1+ and Her 2+ subgroup of patients, excellent safety profile.
    That's why it will prevail. This can actually be the start of a PR campaigne leading to Q4 2015, Q1 2016. Interesting times ahead.

    Sentiment: Strong Buy

  • Here's some free advice:
    A) clarify courts's decision in writing
    B) state the impact of the decision
    C) state your next steps and why they are worthwhile to implement
    D) reorganize executive
    E) commit to frequent updates to shareholder regarding this issue
    F) reitorate your focus on hitting sales targets
    G) clarify what will be submitted / published regarding 301, and when you expect to communicate it ( I have provided ECC guidelines earlier)
    H) use your super key investigator as your best and most credible vehicle.

  • Reply to

    Cleaning House....

    by danindenver33 Aug 8, 2015 2:21 AM
    francolaval francolaval Aug 9, 2015 8:19 AM Flag

    Definitely warranted. Partnership potential hindered. They should reorient Dr G.Peoples within the executive ranks.

  • The European CanCer Organisation (ECCO) will release abstracts for general viewing, provided authors have consented, on its website on 11 September 2015. Abstracts where authors did not consent to early release will be published online on the first day of the Congress, 25 September 2015.

    Abstracts selected for oral presentations and late-breaking abstracts will only be released for general viewing on the ECCO website on the day of their respective presentations.

  • Reply to

    Point of Futility

    by lateshownegma Jul 20, 2015 5:21 PM
    francolaval francolaval Aug 3, 2015 2:27 PM Flag

    Very interesting post. Recurrence rate may be lower in phase III because of the higher homogeneity of the patient population vs. phase II. But again, you have to factor European rates. The question to ask GALE is that will they wait until the 70th patient to communicate the futility results or will they communicate the results as soon as that milestone is reached?

  • Reply to

    PIII oncology trials

    by dmakuria Aug 3, 2015 2:10 AM
    francolaval francolaval Aug 3, 2015 8:35 AM Flag

    Well stated. In addition, immunotherapy in breast cancer is still at its infancy stage. Immunotherapy with Neuvax is where pharma is going - that is: TARGETED THERAPY. To achieve targeted therapy, phase II trials must be analysed fully in order to establish the targeted population and the HYPOTHESIS for a large phase III trial. The fact that futility will be tested, is yet very cleavor. Enough with data mining comments. It's old nonesense comments. Plain old, easy, comments. It's not understanding targeted therapy in a heterogenous population. Pharma/biotech are going in that direction to achieve targeted therapy. There are a few papers out and more papers that will come out that will support PEOPLE/MITTENDORF theory of why Neuvax works in the targeted population tested in the phase III trial.

  • francolaval francolaval Jul 31, 2015 3:51 PM Flag

    Drop out should be the same in both groups. Similar rates as the phase II. Very good assumptions. So, can you also estimate for the 10% futility? Should'nt this stage be achieved by now? GALE is estimating 70th event to be Q4 2015, So, does this mean that at the 70th event, both futility (at 10%) and 30% recrrence reduction will both be addressed?

  • francolaval francolaval Jul 31, 2015 2:53 PM Flag

    Excellent. As for all clinical trials, there is a drop-out rate, safe to say 5%. Maybe lower in this trial as safety is a non-issue with Neuvax. Can you factor this in your assessment? Also, to clarify, is the futility analysis at 70 events 30%, as per SPA requirement? Or is this requirement at 36 month (or 140?) events? Well done. Exciting indeed.

  • francolaval francolaval Jul 31, 2015 12:05 PM Flag

    See PTLA....another example of passing the futility analysis. See quotes in Dec 2014, then thru February and until now. Spectacular. PR for futility was back in February 2015. Anyways, more power to GALE achieving this mileston.

  • See ANTH....see share price in Dec 2014, then in february/march 2015, then now.
    See press release in Feb 2015 stating that trial had passed futility analysis.

    This is a big picture example of how the market behaves with biotech companies.

    In a few months time, we will have a much clearer overview of GALE's pipeline. Three drugs.
    As I stated before, Mittendorf will not go on a dog and pony show saying what the potential in Neuvax is without having a clear idea of the trial trend. She's blinded too. NO doubt about it. But, she probably knows just a bit more as she's also a physician that has enrolled patients on the study PLUS, she's also recruiting patients on other NEUVAX trials, where there's no blinding.....

  • Reply to

    What is futility? Simple answer.

    by francolaval Jul 30, 2015 10:13 AM
    francolaval francolaval Jul 30, 2015 6:45 PM Flag

    No crystal ball here but range of 90-150 days. I must assume that they have a strategic communication plan- well, I can say that in the pharma world, that's part of the strategic plan I.e. Communications. At this point, they are lining up their ducks.....by then we will also have q3 results. Outlook is positive. They are not in a bad position.

  • Reply to

    What is futility? Simple answer.

    by francolaval Jul 30, 2015 10:13 AM
    francolaval francolaval Jul 30, 2015 3:44 PM Flag

    90 days, around Christmas time. By then, we will have a portfolio clearer pipeline perspective - three drugs. I think that their two commercialized products will help support current cash flow needs and stay afloat for the next little while.

  • Reply to

    What is futility? Simple answer.

    by francolaval Jul 30, 2015 10:13 AM
    francolaval francolaval Jul 30, 2015 1:56 PM Flag

    I assume it's the same rate as the primary end-point. The fact that they added an additional 50 patients adds to the power of the futility analysis. I suspect that if the trial moves forward after the 70th event, 36 month follow-up will yield positive results. I'm a strong believer that when a key investigators speaks as often as she does and hammers the message, chances are she will not put her credibility as stake. In the next 60-90 days, there are important catalysts that will be communicated and this will run up to a 2-4B$ company by then. Once the futility results are known to be positive, it's a 4-6B$ market cap company.

  • Reply to

    What is futility? Simple answer.

    by francolaval Jul 30, 2015 10:13 AM
    francolaval francolaval Jul 30, 2015 10:26 AM Flag

    So, simply put, when tested for futility at the 70th event, if decision to proceed with trial, then the probability of achieving a statistically significant primary end-point result is quite, quite high. According to some estimates made on this board, we are on the right path to significance.

  • From CQ weblog:

    Futility Analysis in Clinical Trials - Stop the trial for futility
    A colleague of mine asked me to explain the concept of “futility analysis” using the plain languages. The question is triggered by the recent news such as “Solanezumab, Gammagard Trials Survive Futility Analysis” In an Alzheimer trial, it even says from the futility analysis, “there is greater than a 20% statistical probability of success in achieving the primary outcome measure of cognitive function preservation.
    During a clinical trial, we can perform interim analysis (or DMC, DSMB review) for three different reasons:
    1.Interim analysis for safety
    1) with pre-specified stopping rule (for example stop the trial if we see # of cases of Serious Adverse Events)
    2) without pre-specified stopping rule (rely on DMC members to review the overall safety)
    2.Interim analysis for efficacy: To see if the new treatment is overwhelmingly better than control - then stop the trial for efficacy
    3.Interim analysis for futility: To see if the new treatment is unlikely to beat the control – then stop the trial for futility - this is called ‘futility analysis’.
    In situations 2 and 3, the criteria for stopping rule for efficacy could be different from the stopping rule for futility, but need to be pre-specified.
    An example for futility analysis: in the beginning of the trial, we assumed 65% successful rate for new treatment group and 50% successful rate for control group. We would like to establish the superiority. In the middle of the study, we did an interim analysis. The interim analysis showed 55% successful rate for new treatment group and 50% successful rate for control group. Based on the results from interim analysis, we can calculate the probability and conditional power: if we continue to finish the study, what is the probability of new treatment group better than control? If this probability is too small and meet the pre-specified criteria, we would stop the trial.

  • francolaval francolaval Jul 20, 2015 11:42 AM Flag

    Well, as I said in the past, she's THE SUPER KEY, early adopter, knowledegable investigator.She's had a few presentation on immunotherapy this year. She has one upcoming in July. This one in September is quite interesting...update on the phase III........hmmmm....quite interesting....

  • http://boulderpeptide.org/boulder-peptide-agenda

    This presentation will focus of the clinical trials evaluating NeuVax, a peptide vaccine comprised of the immunogenic epitope E75 and the immunoadjuvant GM-CSF. An update on the ongoing phase III registration trial will be presented.

  • September 29th presentation:

    Injecting Hope: Clinical Development of the NeuVax Vaccine

    Elizabeth Mittendorf

    Associate Professor, Deputy Chair Research, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center

    ABSTRACT

    This presentation will focus of the clinical trials evaluating NeuVax, a peptide vaccine comprised of the immunogenic epitope E75 and the immunoadjuvant GM-CSF. An update on the ongoing phase III registration trial will be presented.

    BIO

  • francolaval francolaval Jun 27, 2015 6:15 PM Flag

    She would not present on this particular topic if she saw her own patients on phase 2 and phase 3 trial relapse. She has best clinical knowledge about the efficacy of neuvax. Stay tuned.

  • http://www.mdanderson.org/education-and-research/education-and-training/schools-and-programs/cme-conference-management/conferences/final-pn-brochure-may-28---agenda.pdf