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  • Gee, Texas? Aye! 14 comments
    Aug 31, 2013 1:17 PM | about stocks: GTXI

    Gee Texas Aye = GTXI

    Email joespringernews@gmail.com to be added to my free newsletter, sent this out yesterday:

    Hey Guys:

    There is a new article out on Seeking Alpha about GTXI, a biotech that makes enobosarm, a lean body mass drug for cancer treatment:

    http://seekingalpha.com/article/1666712-gtx-4-reasons-why-this-1-biotech-stock-could-be-poised-for-a-big-rebound

    This is one I have been researching for a bullish article since a press release several weeks ago cut the share price to a quarter of its 52 week high:

    http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID=1848340&highlight=

    Their top line results were much better than first indicated, showing consistent gains in lean body mass compared to placebo. Basically they hit the European targets and showed clear benefit for the FDA targets while also showing overall survival benefit, but there was a discrepancy between responders analysis and continuous variable analysis. From the conference call:

    http://seekingalpha.com/article/1644802-gtxs-ceo-hosts-gtx-power-trials-results-conference-transcript

    "Biren Amin - Jefferies LLC

    Yeah. I have a couple of questions regarding the data. So Mitch, maybe you could talk to us a little bit about the continuous variable analysis because I think in your prespecified analysis in POWER2, you missed on lean body mass with 0.113, but then were significant with this continuous variable analysis. So can you discuss that and whether the regulators may accept this analysis when you go to them? Thanks.

    Mitchell S. Steiner - Vice Chairman and Chief Executive Officer

    Yeah, great question. So, let me just make a comment about that. So it's a very good point. So a responders analysis is an extremely conservative ITT analysis. The reason it's conservative you give no credit to the patients that actually have some information, and so if you say you're going to do a responders analysis at day 84 that means if a patient comes in at day 42 and has done stair climb and you've measured at DXA and they don't come in for the day 84 visit, they're zero. And so, you only give credit for those patients that make it to day 84. So if you die you get a zero. If you don't commit to the assessment, you get a zero. If you drop out, you get a zero.

    Whereas in continuous variable, you are allowed to look across the spectrum all times. So you're looking at day 42, day 84, day 147. So you essentially are getting an average if you will of what's happening to the patient over that period of time and you get partial credit for patients that at day 42 may have come in and whatever that data is, it's in the evaluation. So by getting partial credit it takes you clearly over the top...

    ...So we feel that the data that we have in both studies and pooled is sufficient to go to the regulatory agencies now. I mean, again we did not expect to have a drug that increases lean body mass, improves physical function also have a survival signal with these fewer event. We're empowered for 844 events. And so this is very, very encouraging and we do believe that it's sufficient to go to the agencies, in particularly the FDA, because for Europe we believe that all the prespecified endpoints for Europe are primarily met. And having a safe drug, I can't say safe, well tolerated drug we did not see any safety signals. And having the potential for a survival signal really again changes the character of the drug.

    And so for Europe, we're going to meet with them and move ahead and with U.S. this is a different discussion. This is a different discussion. So the question is we already fast track with this indication."

    There has been a lot written on this one so I may not write an article, but the catalysts look to be this year as they will meet with both the FDA and EMA before the end of the year. Here are all the Seeking Alpha articles on GTXI:

    http://seekingalpha.com/symbol/gtxi

    The Street had a bearish piece to be aware of:

    http://www.thestreet.com/story/11974668/1/the-gtx-cancer-muscle-wasting-drug-studies-will-fail-heres-why.html

    But we side with the rebuttal:

    http://seekingalpha.com/instablog/594802-jjschaible/2107232-the-coup-de-grace-to-the-feuerstein-thesis-on-gtxs-enobosarm-phase-2b-data?source=kizur

    Please do your due diligence on this one if you like it, I like it but there are no guarantees.

    All the best,

    Joe

    Disclosure: I am long GTXI.

    Themes: biotech, cancer, lean body mass Stocks: GTXI
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Comments (14)
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  • Bio Bull
    , contributor
    Comments (227) | Send Message
     
    Reading what's here as well as the article by Trade in Mexico, I have to admit it sounds like a really good opportunity. I like the short-term potential in particular. Thanks for sharing this, Joe.
    31 Aug 2013, 01:45 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2169) | Send Message
     
    Author’s reply » Thank you Red Bull.
    31 Aug 2013, 01:52 PM Reply Like
  • goinglong2020
    , contributor
    Comments (125) | Send Message
     
    I agree Red Bull - I think the short term looks good - should get some momentum.

     

    Hey Joe - would you look into CUR? Trying to understand the significance of the recent S3 and 144 .
    31 Aug 2013, 01:48 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2169) | Send Message
     
    Author’s reply » I'll look into it when I have time, almost quadrupled in the past 12 months..
    31 Aug 2013, 01:56 PM Reply Like
  • Bio Bull
    , contributor
    Comments (227) | Send Message
     
    I'm looking heavily into CUR right now :) I'd like to release a fairly detailed piece on it because I like their research, and I think a lot of people don't know about them or understand why they have high potential.

     

    I've been getting a feel for the S3... some think they could be preparing for good news in the future and would want the opportunity to capitalize on it. Some of the recent analyst comments by Aegis (in August) indicated they believed Neuralstem has sufficient cash right now to continue well into 2014, so I'm not sure they need it immediately.

     

    I may deliver something on SA within a week or two.
    31 Aug 2013, 01:58 PM Reply Like
  • goinglong2020
    , contributor
    Comments (125) | Send Message
     
    There is some speculation that we could be hearing good news in early September @ the Rodman & Renshaw Healthcare conference. At any rate, there should be some reporting on ongoing trials in the near term.

     

    As fot GTXI, took a small starter position just ahead of Joe's newsletter release. As a small-time novice investor, I feel much more confident in my choices when I know Joe is long on them as well.

     

    Thanks as always Joe!
    31 Aug 2013, 03:16 PM Reply Like
  • petethepanzer
    , contributor
    Comments (937) | Send Message
     
    So a responders analysis is an extremely conservative ITT analysis. The reason it’s conservative you give no credit to the patients that actually have some information, and so if you say you’re going to do a responders analysis at day 84 that means if a patient comes in at day 42 and has done stair climb and you’ve measured at DXA and they don’t come in for the day 84 visit, they’re zero. And so, you only give credit for those patients that make it to day 84. So if you die you get a zero. If you don’t commit to the assessment, you get a zero. If you drop out, you get a zero.

     

    Whereas in continuous variable, you are allowed to look across the spectrum all times. So you’re looking at day 42, day 84, day 147. So you essentially are getting an average if you will of what’s happening to the patient over that period of time and you get partial credit for patients that at day 42 may have come in and whatever that data is, it’s in the evaluation. So by getting partial credit it takes you clearly over the top.

     

    So we feel that the data that we have in both studies and pooled is sufficient to go to the regulatory agencies now

     

    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

     

    LBM1 LBM2

     

    p value RA 0.026 0.013 X 0.68
    p value CV 0.0001 0.0036 X 0.67
    31 Aug 2013, 05:49 PM Reply Like
  • sheldond
    , contributor
    Comments (1024) | Send Message
     
    Joe,

     

    Thanks for the new idea. I love these beaten down opportunities. Still looking into this one it looks pretty interesting.

     

    Have a good long weekend....at least I will have enough time to read.

     

    Best,

     

    D
    31 Aug 2013, 10:24 PM Reply Like
  • petethepanzer
    , contributor
    Comments (937) | Send Message
     
    i find it hard to believe there was not a good frequency of responders in both drug arms considering that its just a more selective version of an anabolic steroid like oxandralone

     

    also joe did it really take 10 days to repost some paragraphs from the conference call
    1 Sep 2013, 12:39 AM Reply Like
  • Joe Springer
    , contributor
    Comments (2169) | Send Message
     
    Author’s reply » I did not say it took me 10 days to write that!! I hadn't started writing at all - research everything first, then write. Trade in Mexico's article let the cat out of the bag and I wanted to tell people about it.
    1 Sep 2013, 12:15 PM Reply Like
  • petethepanzer
    , contributor
    Comments (937) | Send Message
     
    yea you didnt say but theres 10 day gap in your comments

     

    were you just twiddling your thumbs for 10 days ignoring SA
    1 Sep 2013, 12:27 PM Reply Like
  • Joe Springer
    , contributor
    Comments (2169) | Send Message
     
    Author’s reply » It's good to be missed!

     

    I didn't want to tip my hand, but then the other article came out.
    1 Sep 2013, 12:58 PM Reply Like
  • aaeid
    , contributor
    Comments (33) | Send Message
     
    Hi Joe,

     

    Thanks for sharing this. What do u think of CYTK?
    2 Sep 2013, 06:01 AM Reply Like
  • ChrisGriffith
    , contributor
    Comments (104) | Send Message
     
    Joe,
    Big day for GTXI today. Do you still see this one as attractive or is it time to sell after the nice run-up?
    19 Sep 2013, 05:44 PM Reply Like
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