Lorbas, We know that NP knows how many SAE's (i

Lorbas,

We know that NP knows how many SAE's (i.e. deaths) the S/C trial has produced.

Since the beginning I was nervous about the "power" of an interim look at the data, always understanding that this is just a subset of the whole trial. I wrote to NP expressing this.

My point being that if we "blow it out of the water" the FDA will give us approval for undeniable effectivity before the whole trial is concluded.

Interim looks are mostly there so the FDA can check that a drug is actually not killing people. Yes, it happens.

Now, we know we don't kill people and need to convince FDA that a longer trial will just indirectly do so by denying a super-duper drug to users that can benefit form it.

Come NP declaration:

Quote:

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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.

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So, first of all: why the unfortunately ?? I take it because people has died.

Now, patients dying is good or bad for us?? In principle, Leronlimab has 2/3 probability of having a death and placebo 1/3 (by number of patients only). However, more deaths will produce a more deterministic result (for or against us).

The larger the number of patients in the trial the larger the resolution power of the trial (or, that Leronlimab works and the results show it doesn't). So, in principle, a larger cohort should work in our advantage (if our drug is effective).

What about the "quite a bit of deaths" statement ?? Well, he does not know where they come from (or shouldn't know) , so he cannot qualify them one way or another.

Let's asume (for the sake of argument) that he knows that 22 patients of the first 50 died (44%) as where reported in SAEs. This, imo can be qualified as "quite a bit deaths".

Now, it si possible that these are 11 in P (Placebo) and 11 in L (Leronlimab). This would produce a good p-value of 0.011, however, this means that the P group had 64% deaths (a bit larger to what has been reported lately but quite possible).

So where I am getting to ??? Quite a bit of deaths is not necessary a bad omen, but a very large number of deaths will be. Why ???

Let's asume that there where 32 deaths in the first 50 patients (64% total): 14 in the P and 18 in the L group. We still have a good p-value (0.0098). But, wait a minute !!! the P group has 82% deaths. imo this is not plausible (too large) and the likely conclusion is that the L cohort had more deaths (meaning the p-value is higher).

In conclusion: some deaths is good for the power of the results, too many are not good omen for the trial p-value as there where only 17 patients in the placebo group.

Of course, all the above is just exercises on possible outcomes taking into account that NP told us that there where "quite a bit of deaths" and assuming he was referring to 50 patients.