I am not sure 8 patients per branch, or 17:8 is good enough for statsig to continue phase 3. Are they so sure 25 definitely has the significant power? especially their inclusion criteria are very simple.
Hey, old timers, forget today's trading activity. How do you think about the trial design of this newly posted?
May start at march, 25 patients, 12(or you can say 10) weeks, double blind, 3 branches(15000, 7500, 0).
Sounds more aggressive with dosing, confident with time to response, and stingy with cost. Do they really have very supportive data with this trial design?
I guess we will get good result from pediatric patients. Damages have been done on adults and hard to bend immune system in short time. Since it works on young adults, it will work great on young kids. We'd better run a phase I on little kids. Autism, type I diabetes happen to kids more often, and we need safety data to continue.
All these school-run trials will give us some ideas what kinda people are responding to TSO. For research interest, they might run a lot of test on various markers to see what's going on with patients' immune systems. These categorizing criteria, at least at current time, turned out to be more important than running only one efficacy trial.
The trial is ongoing, but the last enrollment was on off-TSO phase (4 months long?). My guess is that most of 15 patients have already finished the whole trial and the raw data are at hand. The final analysis will be released next year. My question is that if they are sharing the raw data with us by NOW. It's not official data, but it really helps us with future plan and back analysis. We were not main sponsor of that trial, but we are the force to move all these TSO forward, so sharing raw data with cndo's scientists in a timely manner may help everybody, including other medical school's trials.
Wondering if Dr. Fleming will share his HINT-2 data with us before he publishes the result. This trial lasted for 10 months and was supposed to publish in 18 months. Last month, he started collecting the data, I assume. This piece of data may give us some hints if 12 weeks is too short for tso to kick in and help us with trial design and analysis.
Now the big problem is that we don't do biomarkers for patients, except for CDAI score. I still believe there are chance for crohn's. But which sub-group?
Comet-2 started half year ahead of comet-1. In non-English speaking countries, there were no holding 2 for 1. Even in English speaking countries, the trial sites are not the same. So we can assume there were some comet-1 enrollments. Now with all patients pushed to comet-2, we may have full enrollment in a month(2 months after comet-1 full enrollment) or so if 100 enrollments/month work the same magic.
The interesting thing is that nobody is talking about EXAM. It's been postponed from march to 4th q of 2013 and then 2014. If the trend of 42% to 75% of events continues, we will have bigger and bigger ratio of survival patients between on-drug/placebo . So the longer we wait, the more favorable OS will be. Seems nobody cares, but it's really good sign for other indications.
Yeah, my feeling was that if they double the size of trust-2 existing result, p will be less than or close to 0.05. We will see. They have to combine both trials data. They should spend one more million bucks on biomarkers. Too overconfident.