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Joe Springer
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  • GTXI - Clear Efficacy For Enobosarm 7 comments
    Sep 1, 2013 3:09 PM | about stocks: GTXI

    Enobosarm:

    (click to enlarge)

    Disclosure: I am long GTXI.

    Stocks: GTXI
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Comments (7)
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  • bholly1191
    , contributor
    Comments (20) | Send Message
     
    As always joe, appreciate it! Will obtain some hopefully on Tuesday.
    1 Sep 2013, 03:40 PM Reply Like
  • sheldond
    , contributor
    Comments (1456) | Send Message
     
    Hmmmm pretty interesting chart. So it seems enobarsom is like performance enhancing drugs for cancer patients.

     

    I always enjoy a beat down stock. What are the closest major catalysts here?

     

    D
    2 Sep 2013, 11:02 AM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » They go to the EMA and FDA this year, they are already fast tracked with the FDA, could get good news from either this year.

     

    http://bit.ly/18ycj7V

     

    "And, no, we’re not going to wait till first quarter of next year. That’s a safety endpoint and we feel pretty good now with almost 62%, 65% of the deaths reported that what we need to be focusing on is the value of lean body mass having a drug that can intervene i.e.; build lean body mass, and having evidence that needs to be confirmed that building lean body mass improves survival."
    2 Sep 2013, 04:57 PM Reply Like
  • sheldond
    , contributor
    Comments (1456) | Send Message
     
    Thank you sir.

     

    It would seem obvious that losing lean body mass makes every physical activity extremely difficult. Quality of life is an important aspect here. Many cancer patients become so weak from loss of lean body mass that they are unable to live their life how they want.

     

    I could definitely see where this could combine with other treatments.

     

    Anyways thanks for sharing...now I just have to do risk analysis.

     

    Best,

     

    D
    2 Sep 2013, 07:07 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2650) | Send Message
     
    Author’s reply » FDA fast tracked it as an unment medical need, there had been plenty of evidence of death associated with loss of lean body mass but this is the first study showing survival benefit from therapy increasing LBM.
    2 Sep 2013, 08:17 PM Reply Like
  • petethepanzer
    , contributor
    Comments (1055) | Send Message
     
    DAY 84

     

    LBM1 LBM2 SCP1 SCP2

     

    p value RA 0.036 0.113 0.315 0.289
    p value CV 0.00003 0.0227 0.0336 0.792

     

    DAY 147 - only this day for RA, no zeroes counted

     

    LBM1 LBM2

     

    p value RA 0.026 0.013 X 0.68
    p value CV 0.0001 0.0036 X 0.67

     

    the RA p value tightens up alot for day 147 for power2 trial

     

    survival benefit 20% HR seen in each trial with n= 70, since 280 events

     

    ...therefore permitted a look at pii with 20 and 30% survival HR and some literature with strong signals showing muscle correlates survival infer the reversal with 3 small n lightning strikes 3 times

     

    Body mass index (BMI) distribution was 17% obese, 35% overweight, 36% normal weight, and 12% underweight. Patients in all BMI categories varied widely in weight loss, muscle index, and muscle attenuation. Thresholds defining associations between these three variables and survival were determined using optimal stratification. High weight loss, low muscle index, and low muscle attenuation were independently prognostic of survival. A survival model containing conventional covariates (cancer diagnosis, stage, age, performance status) gave a c statistic of 0.73 (95% CI, 0.67 to 0.79), whereas a model ignoring conventional variables and including only BMI, weight loss, muscle index, and muscle attenuation gave a c statistic of 0.92 (95% CI, 0.88 to 0.95; P < .001). Patients who possessed all three of these poor prognostic variables survived 8.4 months (95% CI, 6.5 to 10.3), regardless of whether they presented as obese, overweight, normal weight, or underweight, in contrast to patients who had none of these features, who survived 28.4 months (95% CI, 24.2 to 32.6; P < .001)...n=1473 patients

     

    if one agency overlooks stair climb in favor of survival then there is still a possibility of approval here
    3 Sep 2013, 03:36 AM Reply Like
  • sheldond
    , contributor
    Comments (1456) | Send Message
     
    I think we might want to look at this again. Any thoughts? I love it when they get beat down.

     

    Seems like some trials might be coming, seems a little cheap just the way I like it. Downtrend not so good but we are approaching resistance buy now and at .50 if it drops....covered either way.

     

    Best,

     

    D
    17 Sep 2014, 04:32 PM Reply Like
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