I don't think NP wasn't clear. Is just that he ca
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Posted On: 07/02/2020 6:50:34 AM
I don't think NP wasn't clear. Is just that he can't say too much.
He referred to big pharma in this context:
Also, in regards to deaths in this context:
So, he knows how many people died. He just doesn't know in which arm.
Let's assume a 51 patients trial (37 Leronlimab VS 14 placebo). If 35% die in placebo we have 5 deaths. If we have 2 there will be a total of 7 deaths.
This is good news and bad news. If nobody died, that will mean the trial will not produce statistical results. Let's say that only two died in the placebo and none died in the Leronlimab, the test would be a failure.
Three die in Placebo and none in Leronlimab: there will be statistical significance but imo FDA will not approve.
You get the point. More deaths will produce (possibly) a better statistics PROVIDED the drug arm does not have many deaths.
So what does "quite a bit of deaths" mean. Say 8-9-10-11-12 total (I am guessing here).
So:
8 deaths (6P-2L) We will have a good number p=0.0082
9 deaths(7P-2L) will be even better
10 deaths (7P-3L) good number p=0.006
11 deaths (7P-4L) statistical significant, but FDA will approve ?
12 deaths (8P-4L) very good number P=0.004
These are some scenarios. As you can see, it is OK to have quite a bit of deaths (please note, I am sorry these are happening, this is not an unsensitive comment, I am just refereeing to what he said) provided L (Leronlimab) ones are small (of course).
He referred to big pharma in this context:
Quote:
We have been reached out to by big pharma and big-mayor media to talk about this data as soon as it comes out so there is a lot of anticipation for this data anticipation for this data last Wednesday
Also, in regards to deaths in this context:
Quote:
In regards to our critical: patients for CD-12 we have about 120 patients enrolled, so we have quite a bit of data and unfortunately quite a bit of deaths have been reported at the serious adverse events which we get to see: we don’t see the data because is blinded, but we get to see the serious adverse events. Now, we believe that we get in both of these data one of them hopefully we could do Interim analysis at some point if FDA allow us, and the CD10: If we get both of them to FDA and if get approval the question is not how quick we could get approval which we believe hopefully it will be soon, but how can we distribute this product.
So, he knows how many people died. He just doesn't know in which arm.
Let's assume a 51 patients trial (37 Leronlimab VS 14 placebo). If 35% die in placebo we have 5 deaths. If we have 2 there will be a total of 7 deaths.
This is good news and bad news. If nobody died, that will mean the trial will not produce statistical results. Let's say that only two died in the placebo and none died in the Leronlimab, the test would be a failure.
Three die in Placebo and none in Leronlimab: there will be statistical significance but imo FDA will not approve.
You get the point. More deaths will produce (possibly) a better statistics PROVIDED the drug arm does not have many deaths.
So what does "quite a bit of deaths" mean. Say 8-9-10-11-12 total (I am guessing here).
So:
8 deaths (6P-2L) We will have a good number p=0.0082
9 deaths(7P-2L) will be even better
10 deaths (7P-3L) good number p=0.006
11 deaths (7P-4L) statistical significant, but FDA will approve ?
12 deaths (8P-4L) very good number P=0.004
These are some scenarios. As you can see, it is OK to have quite a bit of deaths (please note, I am sorry these are happening, this is not an unsensitive comment, I am just refereeing to what he said) provided L (Leronlimab) ones are small (of course).
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