I have to wonder about the timing of management for the 64th event. i don't know if they ever told us their assumptions for coming up w/ their prediction of end of 2013 or early 2014, or if they ever predicted the 32nd event timing, (anyone know?). What I do know is that the 32nd event pr was in June 2013 (but when that occurred is not known). The trial started Jan 2011 and ended around Oct 2012. There were around 83patients on ICT107 and 41 in ctrl.
Here are my scenarios:
years 1 2 3
Ctrl 40% 16events 70% 29events 80% 33events
A. ICT 107 (using pI results) 0% 0 events 20% 17events 45% 37 events
B. ICT107 (same as SOC) 40% 33events 70% 58
C. ICT107 (24mth med OS) 30% 25 events 50% 42
D. ICT(better than 24mth) 20% 17 events 40% 33events
Using the above table: I chose Jan 2012 as the mid-point of the recruitment. The 32nd event reported 6'13 means event occurred less than 1.5yrs from midpoint. This means that scenario A,C, and D are possible and B is not (based on the assumption that DMC would have stopped the trial if scenario B was seen but I don't know for sure.) I'm picking D. as the best matching scenario so far.
Now, my estimate for 64th event:
A. 3Q 2014
These are just VERY rough estimates based on many assumptions, but I do hope that the PR for the 64th event occurs later in 2014. Did management state that they will not reveal the 64th event timing before releasing the data?
Why does anyone believe that the 64th event will happen any time soon? Aren't some of the phase 1 patients, & correct me if I'm wrong, who received ICT-107, still alive? We can assume that almost all of the first 32 events were the patients in the control group that received a placebo &the regular standard of care treatment. Is there a definitive reporting date for the # of events or will they wait until 64 events have transpired. I'm a bit confused on this aspect of the trials- any help! Thanks!
83 patients on ICT-107 & 41 are not, of the 124 . The stats will be better than only 19 (ICT-107)survivors, considering that just about all of the placebo group will have expired. Not that 19 patient survivors of the 124 wouldn't be very good. I have a feeling it will be considerably better. I will pray- please pray for these people in this trial. We need to humanize what we have been referring to as "events". They are people w/ families & many may not be ready to die(esp. in a Christian sense)
You do nice work. The original company projection for the 32nd event was 4th Q 2012. I'm guessing 32 occurred end April, pr released six weeks later. They missed by 4 ? months. Imuc should hire phishes3.
Are you using the full enrollment curve once found on the co. website? It was removed 1 yr ago.
Do you know it was announced 6 weeks later? My understanding was that it was just the number - no compilation of data etc.. Which could only be done by unblinding, therefore, not the lag in place for 64. I think this question was treated in one of the ensuing webcasts...
Sentiment: Strong Buy
Thanks, but my stats knowledge is very limited compared to the other guys on this board. I've only been doing dd on imuc for less than 1yr so I havn't seen the enrollment curve so I must estimate. i remember management stating that the DMC most likely took several weeks after the 32nd event to report it to IMUC so I'm dating it around early may '13. So barring an unusually large cluster of events last quarter and this quarter in the treatment arm, even a layman like myself can see that the probably of reaching the 9mth advantage or better is very good. For IMUC I do believe that no news is good news. I do expect IMUC to PR the top line results whether good or bad before doing their 3-4mth of data confirmation and analysis. I really am hoping for post pII approval and a conditional pIII post approval trial with NO ctrl grp because of ethical reasons, but I do concur w/ management in just waiting patiently for the results- because crazy things can happen in biotech.