Gee Texas Aye = GTXI
Email email@example.com to be added to my free newsletter, sent this out yesterday:
There is a new article out on Seeking Alpha about GTXI, a biotech that makes enobosarm, a lean body mass drug for cancer treatment:
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:
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:
"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:
The Street had a bearish piece to be aware of:
But we side with the rebuttal:
Please do your due diligence on this one if you like it, I like it but there are no guarantees.
All the best,
Disclosure: I am long GTXI.