BioPub video re interim report I watched this.
Note that (over the world, I think they meant) 85% recover, most of them not going into ICD, and with Remdesivir there is a 19% reduction in ICD and mortality.
So the positive signal will have been the lower time spent in ICD by the 50 on the high dose and the 50 on background care (differeing in the different countries, mainly Romania, Phillipines, and USA, with a few in Australia)
19% of 50 is about 10. So we are talking - roughly - of what happened to 10 of the high dose 50.
I am guessing that a “positive signal” and “good news” must mean this was a difference of some number larger than just 2 and smaller than 8 - though I emphasise I don’t know. I just find it easier to think with examples than abstractions. The problem of course is that we are into the statistics of small numbers, so if in theory you repeated this trial a hundred times, and there really is a reason for a positive signal, you might get varying results anyway, varying around whatever mean result is justified by the good effects of idenprofil (assuming there are any). i.e. if, on average, 45 out of 50 would survive, individual groups of 50 might have 41, 46, 48, 40, 50, 43, etc etc etc surviving. This interim data set is only one of those. I just think that if the number were higher than 8 they would have been very excited. Though they don't seem the excitiable types to me.
So, such as it is it is good news, but not very significant, and even a very good result when we get the full Phase 2 data in February will still not be extremely significant - you need the larger numbers of a Phase 3 trial to get the extra significance you need.
Apart from the fact that we have “a positive signal” we already knew all the above before we heard about the interim data, so getting all excited over possible very good news was just getting over-excited.
Note that:
Algernon did not know this was what they were going to find, because it’s a blind trial, so castigating them for coming out with this data is silly, though you could perhaps rightly say they were taking a risk in releasing any interim report at all.
The reason they came out with it was because
- they didn’t want Algernon to fall off everyone’s radar because the vaccination is
on its way. They have good reasons (long COVID, many not taking the vaccine)
to think COVID and related cases will be around for a long time yet
- they have good reason to suspect that ifenprodil will help
( that’s why they’re doing the trial for God’s sake !)
- therefore there was a reasonable prospect that the interim data would be good
- maybe unconsciously they couldn’t resist having an early peak (!)
In the event, the result was frustrating, because
- given cash limits, they were not providing interim report on every end-point
- the main good news coming out was only on the one end point
(there might have been more, but some of the other end-points
were not reported on)
- no good news from the lower dose
- market may have been unaware of how useful “less time in ICD” would be
- market may have been unaware of future possibilities in Phase 3, e.g.
- higher dose still
- longer period of dosage
- better results with optimum background treatment
- and on and on (other end-points)
none of which means that ifenprodil is any less likely to be effective than we hoped it would be before we had the interim data.
So maybe when we look back in a year’s time we will see that the sp has
- dropped to take out the over-excitement about “we’re getting data!”
- increased to take into account that, to a small extent, the news was good
- and nearer February, increase for the repeated over-excitement “we’re getting data!”
We’ll see. I am staying in, with a modest investment, because of the good indications re chronic cough - which is the main project of this company - as well as the chance of good news re the lung-related long Covid, and maybe even the short Covid as well as indicted by this interim repoirt.