john, if you do a search on google for "LV Dysfunction and the Viable Myocardium A Therapeutic Upgrade of Metabolism by Gene Therapy" you should see a link to a pdf with 2 slides on remodeling domain and one of the slide should provide you with the EF data you are looking for.
john, since the effect of mydicar for the two lower doses do not last long it's possible what we are seeing at 9 and 12 months are the natural progression of the disease. as to why EF is larger than control, it could be we are seeing the worsening of the sicker patients who where initially helped by mydicar; kinda like how there would be a sudden flood of water when a dam starts to break down. this effect can be more clearly seen when you look at the cumulative clinical event rates slide.
our only chance to see the raw data would be after an nda is submitted for mydicar and the fda requires an advisory committee to be held for this drug.
mclim, the enrollment criteria for picasso 3 is quite different from th-cr-406. what stuck out for me with regards to picasso 3 is: patient has not received any prior treatment, and there's no exclusion of low grade. so, i think it's possible picasso 3 may have enrolled healthier patients. but can't say for sure since i can't find any info on the breakdown for the patient population.
picasso 3 exclusion for prior treatment is a little misleading since i just noticed they do allow neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease. So this is similar to th-cr-406. So, it seems exclusion of low grade may be the only major difference, at lease as far as i can tell.
yes, chalwa was an investigator on our phase II trial and he was even a presenter at one of the scientific meeting. both trial also excluded patients with systemic therapy but only thld excluded low grade. i wonder if if the longer survival in picasso 3 is due to enrolling low grade patients as Stewart Kroll had stated. No way to know until they release the baseline patient characteristics. do you have any idea if they intend to do so?
i still think control os will come in under 12 months since i think our enrollment criteria is more similar to EORTC. i'm also not giving the picasso 3 os much weight b/c our enrollment is quite different than theirs and we don't know their paitent's characteristics.
mclim, what gives me optimism for a successful interim is based on two facts. fact one, there was high demand for the th-cr-406 trail. picasso 3 took almost 2 years and 150 sites to enroll 447 patients while th-cr-406 trial took 2 years and about 100 sites to enroll 620 patients. we can clearly see the difference in demand for these two trails. but demand alone would not be enough to give me optimism. it is the high demand coupled with the second fact that this is an open label trial. The doctors at each site can obviously see the difference btw control and treatment for the patients they were treating. now you have to ask yourself, if you were not seeing a benefit for your patients, would you still continue to enroll them into a trail and expose them to additional side effects. Instead, what if you were seeing a clear benefit? would you not press to add more patients to the trail? recall, one of the reason for expanding the trial to 620 was b/c enrollment rate was stronger than expected.
I know thld management has attributed the high demand to good site selection but we shouldn't discount the fact that doctors knew if the treatment was benefiting their patients. sure i'm sort of reading tea leaves but i believe these two facts are good hints th-302 is showing a meaningful benefit in this trail.
john, if you want baseline patient characteristics for each arm, you will see a ppt file if you search on google for "Cardiac Recovery the Hopes of Gene Therapy, Vinay Thohan". the baseline info will be on slide 38. note the high dose arm was in general the healthiest group.
putting bigsmartsta on ignore is like taking a deep breath of fresh air. now does anyone know how i can make it so that instead of graying out his post i can make them disappear completely instead?
I'm not convinced standard of care for STS has really changed that much over the last few decades. for example, the dox arm in the STS EORTC study by Santoro et al. 1995 study had median os of 52 weeks (~ 13 months). fast forward two decades to the recent STS EORTC study which enrolled a similar population and we still get a median os for the dox arm of about 13 months.
As for ziop picasso 3 trial, i'm not putting much weight on their results b/c their inclusion criteria is not similar to ours and there's no baseline data to draw any meaningful conclusion. also, not all trials are equal, some are just better executed and more credible. So, if the results from ziop is in conflict with the EORTC, i wouldn't even blink twice before believing the trials from EORTC over ziop any day.
mclim, the enrollment criteria for th-cr-406 is very similar to the EORTC trials with the exception that the population for th-cr-406 will be older and likely sicker than those in the EORTC trials.
sure, we don't know the baseline characteristics for the th-cr-406 trial but the patients enrolled should be similar if not the same as those enrolled in the earlier phase II trail. So, it's not a stretch to assume patients for this phase III trial will be similar to those in the EORTC trail since that was the case for the phase II trail.
mclim, another thing that gives me faith in a successful interim is the eta for the interim readout is within the high end of the company's projection. so, the chances are good the os events are coming in at a rate that's within the company's expectation telling me that the trial is playing out as designed.
your are absolutely right, there's no guarantee, but that's always been the case for clinical trails. It's all a game of odds and to some degree skill.
mclim, both trails seems to attempt to answer the same question of which is better? dox alone or combo. in the earlier study, the trial had three arms; dox alone and two combo regiment one of which contained ifosfamide. it seems the result from the first trial did not provide definitive data on when ifosfamide should be used if at all. So, the second study is just between dox and ifos combo with a different combination than the previous trial. in the original study, the ifos combo was Doxorubicin 50 mg/m2 + ifosfamide 5 g/m where as the current study has the combo as Doxorubicin 25 mg/m2 d 1-3 + Ifosfamide 2.5 g/m2 d 1-4 + Neulasta 6mg s.c. d5. is the question answered this time? who knows.
sell_4, i sure hope you're not all talk and no action but people like you usually are -- all bark no bite. if you have any bite to you why don't you disclose how much you are short thld. if you have no guts to put your word in to action, than you're no better than some no life wannabe. sure hope you prove me wrong and that you're heavily short thld.
can't agree more beach.... no pain or regret from this thld long... since i can careless about these trader induced volatility. i got in at a good price and if the phase III trails succeeds in getting th-302 approved by the fda, i'll be laughing at these shorts and idiot traders while enjoying my early retirement.
demoralizing? only if you're an amateur in biotech investing or an idiot short term trader. for those who's been around the block a few times, this is just another opportunity to average down. any season biotech investors know the only thing that matter is the trial data and science -- not market volatility.
thanhle, it doesn't take a lot of brain to follow the market which is why you're doing it. you didn't predict this biotech beat down; don't fool yourself thinking you're any smarter than the herd. thld's price action has nothing to do with thld so stop patting yourself on the back for something you didn't even see coming until it smacked you in the face. the only people who would be frustrated by this melt down are you traders; for longs, this is just another opportunity to average down. clown
beach, down markets has the effect of causing the #$%$ to bubble up to the top. let them have their sick orgy. it's a matter of time b/f they sink back down to the cesspool from where they came.
these low life back slapping chump thinks the world of themselves b/c they are experts at chasing the market like a chicken with it's head chopped off in their silly attempt to churn pennies. do continue to tell us how we missed out on the next big thing after the fact. non of you penny churners have the balls or brain to sit through a binary event but yet you all claim to know what stocks to invest in? i'm sure when thld hits its endpoint you'll be promoting thld at some other board claiming you were there when the stock was trading in the 3s. chumps