Ok, so I had a look at my numbers.
Here are some thoughts and then numbers provided based on that
Essentially the 928 population is misleading regards relevant for the trial outcome.
The distribution of 3/7, 3/7 and 1/7, for SOC + Multikine + CIZ, SOC alone and Extra group, mean that we really have 794-795 patients that are actually in the clinical trial outcome relevant 2 groups of SOC + Multikine + CIZ and SOC alone.
Therefore, applying the guy's survival rates to the correct sample of 6/7th of the total sample and assuming a 1:1 ratio of SOC + Multikine + CIZ and SOC alone at each month's enrollment, I have proceeded.
Also one point that I look at differently to your calculations is that I am not paying attention to the 42% treatment response, as we are talking about 8 patients from a total of 19 and of which really only 17 are good.
In my calculations the key point I pay attention to is what the FDA will be looking for. 10% increase over SOC.
Therefore for my numbers.
If Multikine + CIZ were just as effective as SOC, then by May 2018, expected events would be 295.
If Multikine + CIZ were to give 10% superiority, then by May 2018, this would be 265.
Now again we look at the event rate and I see that every 3 months we have between about 25 to 29 events. I will use the lower 25 events.
Thus if we can use the 25 events every 3 months and that we are almost 3 months from May 2018.
The events up to nowish if Multikine + CIZ were as effective as SOC would be 320. If Multikine + CIZ were to provide 10% superiority the we would expect to be at 288 events, which would have us off by 10 events at the moment. Thus we would hope the trial will not conclude within the next 2-3 months, so that we can hope that when the 298 is reached that this should hopefully mean a 10% improved survival.
This of course would be based on our current understanding and statistics to hand, but does not guarantee anything.
Even moreso now I do hope the trial goes on for another 6 months at least to have greatest confidence prior to unblinding. Given I have heard nothing from Cel-Sci on partnership discussions, I feel this will definitely mean that more dilution is on the way. Just vis-a-vis time.
Exciting and indeed nervous times ahead, let's hope we don't hear anything on 298 events reached for a good few months :)
In the meantime happy to see that we closed well above the 1 USD mark, just 9 more days of this to go to do away with the non-compliance for now. However again after what I expect to be dilution and how much time we are further in, I will consider buying more.
So Lightrock, I would assume that if you didn't go with the 42% response rate that you would reach the same numbers as myself?
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