look at the poster (TH-302 Maintenance Following TH-302 Plus Doxorubicin Induction: The Results pf a Phase 2 Study of TH-302 in Combination with Doxorubicin in Soft Tissue Sarcoma), at the company's website, for the phase 3 trial design if you want to more detail.
the trail design was designed assuming an HR of 0.75. however, if the true benefit is anything like what we saw in the phase 2 trial and if the control is either 12 (as assumed in the design) or less (as historically expected) than the true HR would easily be around 0.6 and could possibly be even near 0.5. So, if the HR comes in at around 0.6 or lower, the interim would be easily powered over 80% to see a significant result.
of course, there's a risk in reading too much into small single arm results, but considering the strength and consistency of all the th-302 data to date, i think the HR for STS is smaller than 0.75; so our chance of getting positive interim results should be pretty good.
smith, if you look at the single agent studies of th-302, you will see they were able to dose up to 670. only when th-302 is dose in combination with other chemo do we see DLT creeping up at smaller doses.
"Confounding crossover and failed EU STS trial" were gifts from an irrational market to those who actually took the time to dig into the data.
the market believes th-302 does not provide significant survival benefits to pancreatic patients and ignored the impact of those who crossed over. the market also seem to have ignored the better than expected survival of the control arm when compared to historical data. the two year survival of the th-302 control arm was about 11% where as the expected 2 year survival should have been between 4-6%. in fact, the 2 year survival for ABRAXANE arm was 9% and it's control arm was 4%. However, note that the ABRAXANE trail had enrolled slightly more sick patients. Still, the population of the two trials were pretty similar so why did the control arm for th-302 live so much longer than the control arm for the ABRAXANE trial? The company has good reason to believe the crossover had improved the survival of the control arm. The question is how much did the crossover help? my guess is without crossover, the hr would have came in at around 0.7. My bet is we will see a hr of about 0.7 from the pivotal pancreatic trial.
the data from the EORTC 62012 trial was a gift. the market chose to focus on the fact that the trial failed. instead, they should have focus on the data from the control arm with 12 months. the population of this trial was likely a little healthier than those in the th-302 phase 2 trail in STS. So, this only adds more cred to the survival benefit seen in the th-302 trial of 21 months. in fact, if you compare the survival curve for the th-302 trail with the control arm in the EORTC trial, you'll see that as time when on, the survival benefit btw this two curves increased. if this trend is repeated in the pivotal th-302 sts trial, there's a very good chance the interim will be successful.
so, obviously the market is moving contrary to my DD. when i see this, i always bet against the market.
the new indication for the next registrational trial will NOT be in glioblastoma. thld has said that the next indication will be larger than either pancreatic or sarcoma and glioblastoma does not fit this criteria.
beach, tim is not an idiot, he's just special.
regardless of what special ed tim says, institutions are not the smart money; they usually only pile in after the fact and almost always over pay.
from my experience, i would prefer it if thld had no institutional ownership at this stage of the development. this way, there would be more "smart money" to fuel the run up should the th-302 pivitol trials be successful.
special ed tim, it's not about when a company became public but when it started. thld was founded in 2001 and celg in 1986. also, celg was not a pure startup since it was spun off from Celanese Corporation. so, yes, celg has been around much longer than thld.
if you were as knowledgeable about biotech as you claim, you should know that it can easily take over a decade to go from startup to having a drug on the market. so there's nothing slow about the pace thld is on with getting is first drug on the market should th-302 be successful.
you never surprise with your ability to show us how special you are. keep up the good work special ed tim.
blame this on the SEC for allowing MM to exists. there will never be a real market as long as we have MMs.
special ed tim, is it to hard for you to comprehend what you read? i said, those are the metrics that matters when looking at companies LIKE thld -- not p&l. but then again, of course you wouldn't understand since you're special.
are you looking at the right ticker? thld is getting taken down with the market. crooks will continue their games until approval is seen as inevitable.
but i agree these take downs on drip volume is a joke. if the data is good for the phase 3 trials, we'll be shooting pass 30.
special ed tim, how many times do you have to be told that p&l analysis is useless for companies like thld. for companies like thld, it's all about clinical data, odds of approval, market potential, pipeline, cash and debt, and burn rate.
take your walmart investing how-to somewhere else.
"Conclusions: The triplet combination of G + nP + T exhibited superior efficacy but additive toxicity was not evident compared to G + nP. These studies provide a translational rationale for combining G, nP, and T in the clinical setting to assess efficacy and safety."
if clinical trials replicate these preclinical findings, this triplet will easily become the standard of care. it's early days, but i like our chances that this findings will pan out.
"crazy market"? according to special ed tim, the biotech market knows best and is smarter than all of us b/c they are governed by biotech pros and institutions.
only an idiot would expect future return to follow past performance ;so, it's not surprising to see seymour behind this idiotic approach to investing.
yes, investing is not rocket science that's why any idiot with a few dollars can do it. if the market was full of rocket scientists, these message boards would be no fun since we wouldn't have posts from idiots like seymour and special ed tim.
hand, you misread the trial info. for pancreatic cancer, th-302 will be given in combination with gemcitabine. th-302 will only be given alone with other solid tumors. the likely purpose of the trail is to support future expansion into japan.