depends on STS interim look. P2 of 21.5 months will not be repeated since the data is not mature. P2 started the PR with 16.5months to 19 months to the final 21.5 months. I expect similar results in ours.
If control is 12 months, i don't think 16.5month is enough to stop the trial. I just hope that they give us the interim OS trend numbers to give us some confidence going into final analysis.
As for stock price, i agree with Dawginlife that we'll be range bound this year, and rise to double digits early 2015 as momo builds on the STS P3 results coming out.
My hope is that if STS is a GO, then people will decide on the possibilities of Pancreatic and Lung, and Prostate, and whole lots of other indications and give us price around $30s to even $50s. this has the platform for it. It starts with STS results. Hoping for interim Homerun in the meantime.
not only that, according to Selick, they were slightly sicker as well. avg age for eortc was 48 vs age of 60 for phase 2. huge difference. im hoping for less than 12 months and would not be surprised if we see 10 months.
Im hoping that they did this in case interim hits...
eortc ifos trial base population vs thld's phase 3 recruits.. are you confident this is similar population dawg? i did my DD and i think our trial is a bit sicker than EORTC ifos trial, do you agree? thanks.
So, we have P3 on Sarcoma that will have top line data mid 2015, and pancreatic end of 2015.
This can be platform for many other cancers such as Lung, Prostatae, melanoma, etc....
this is $100 stock if all makes it through the FDA. 6+B isn't all that much with multiple indications approved.
I would be shocked, if we are not double digits by this time next year on anticipation of Sarcoma trials. We are too early here.. hold and you will be rewarded imo.
i added at 4.50. that said, why the heck is HALO 1 B market cap and we are not? THLD needs exposure and will get it in due time, hopefully with interim look, or top line results sometimes next year. until then we are sitting ducks i guess lol.
that news was know 2 months ago here. the P2 lung cancer study will probably PRed 2 month later as well.
i don't buy the toxic story, i compared the dox arm on the historical data and they are exactly what it should be with THLD arm. as for risk tolerance, yes, i am big on that lol. too big imo.
i am intriged in the sarcoma trial. single arm.. i hate, really hate single arm trial. i don't get any company who does single arm in p2 trials.. really! that said, their p2 study on pancreatic cancer was well ran imo. 3 arm and lower dosage was better than control, and higher dosage was better than lower.
im very confident in the p3 pancreatic cancer and hoping it would beat out abraxine was it? 1.8 months if i remember. im hoping for 3 month for the trial to be homerun. i think 2.5m or better would be considered success.
back to the STS P3 trial, im very hopeful and if historical results (8 to 10 months) or EORTC control of 12.8month, along with P2 type of data on the TH-302 arm occurs, this would absolutely a HOMERUN, you or i both should not sell until we get bought out at triple digits. $100, bah... only 7B... which is very possible with Sarcoma, Pancreatic, Lung, and host of other promissing indications. Should get there in 5 years or so :-)
my retirement fund isn't going anywhere for another 20+ years, so im sticking around.
of course the EORTC PFS for the drug arm was very good against the control arm, yet the OS didn't come close to the PFS. Interesting observation.
One concern I have is that PFS for Phase 2 compared to EORTC control was about 2 or 3 months, yet the OS was greater than 8 months.
I know drugs from DNDN's Provenge has no impact on PFS, and yet the OS is 4 month longer than the control.
any expert out there try to explain this? thanks.
" there's always risk,but it doesn't get any easier than this in biotech investing." This is my current thinking and im very aware of "too good to be true as well"
why isn't everyone in the world jumping on this?
There was a question on one of the presentations about whether the events were know to them, or if they were progressing faster or slower than expectations. Management said that there weren't enough data to know yet, which means you can infer by the answer, the death event is probably known. This is open label study, so i think if you have access to Dr. on charge of the clinical trial, you can find out, which im 100 percent sure THLD has access to.
perhaps that's why they are being so specific of the interim data date.
just in case kinda thing. I pray we get early stoppage, but i can wait a year for the data if need be. my 401k isn't going anywhere anytime soon.
First of all, I believe that the Phase 2 data was large enough that it passes the "smell test."
What it is missing is the comparative arm, the Doxorubincin arm. So in order to have a guestimate we need to see if our Phase 3 trial can repeat Phase 2 results, with control arm having mOS roughly that of EORTC DOX arm or less.
Median AGE of EORTC control arm: 48
Phase 2 of THLD's STS (Dox+TH-302): 57
EORTC did not recurit those age over 60.
1/3rd of P2 were age 60 or greater.
TH-302 is slightly sicker population than EORTC trial according to Performacne Status.
Both did not recruit low grade tumor.
Safety EORTC: Neutropenia - 37%, Leucopenia - 18%, Febrile Neutropenia - 13.5%
Safety TH302+Dox: Neutropenia - 20%, thrombocytopenia - 25%, Febrile Neutropenia - 10%
I compared lots of notes so far, and it seems like we can match or beat EORTC's control arm of 12.8 months.
So if Phase 2 data is accurate, we can expect:
12 months control vs 20 month TH-302, however im pretty sure the interim look will be less in mOS for TH-302 arm due to not having enough event.
Im hoping we can get rougly 11months vs 17months for early stoppage, but if not, no big deal, as im pretty sure we can get 4 month advantage by mid next year. Of course, anything can happen with data, but we also have P3 Pancreatic trial to fall back on if P3 sarcoma fails.
more later and i welcome any comments.
added at end of day.. another 1 share @ 35.45..
now i can make profit on my 2 shares @51 since i can sell both shares and save on commissions!