They really haven't provided much information and have danced around key points . Providing no graph except in regards to smell says it all IMO. I regards to " alluding" to non compliance in younger age groups ? Well I am not sure and that is an assumption they have used to justify failure in that subgroup but they provide no numbers below the 40 yo age group or just HC poster suggesting it?. To allude to it and not provide data after review if they did to follow up - ie such as we did follow up and people under 40 said they failed to follow instructions , busy lifestyle , inconsistent application etc etc. Didn't isolate at all as selfish age group and kids seemed no worse for it , I took some spray so felt bullet proof yadda yadda etc, You do too much of that and it will possibly show large flaw in trial and possibly change power in trial. So what could it be in younger age group? Constant reinfection due to social and work commitments? So does that mean that Viraleze only is viable if you isolate / cocoon yourself like a older population does a s they have the time and ability to not have to attend work, not have kids activity,
The other point they allude to is that vaccination status of younger folk in UK is not same as older group . This will really do in the heads of local SPL conspiracy theorists . So assume the under 45 were compliant in all way including lifestyle So in the UK you need to understand who is able to receive latest booster doses . To compare Viraleze within the ages subgroups in regards to extra booster doses etc and IMO the subgroups become very small statistically assuming the population recruited represents the society in the wild. The likely participants IMO were possibly older population who were concerned about covid and complied but also cocooned themselves etc etc. Bias in older age group because participants selected on both arms of trial possibly don't represent society mix of both vaccination and care around catching covid etc?
I think peer review will have many questions in regard to this trial like they have had with so many other covid based trials . It is nothing new in trials to realise compliance is different in different age groups , situations, ecconomic situation, avaliability of healthcare etc etc To allude to that being a excuse for trial failure is
IMO this is a poor trial for many reasons and SPL unless forced by MHRA possibly would nit have chosen to do it and IMO I believe i was the bare min required to be able to continue selling in UK and try to avoid withdrawal. I suspect it will do near stuff all in regards to TGA etc. So without a further trial to prove up Viraleze in other age groups - risky but if you want to sell it ? where does Viraleze now stand.? Will current packaging be withdrawn and when? Do they need a new box with " only to be taken by over 45 YO in big letters on the outside - that will go down a treat with marketers? Since SPL have claimed same method of protection against all virus by enveloping virus is teh result of this study taht something is different in under 45? Anyone care to mention any other medicines or devices that say - only effective if you are over 45 YO that are out in marketplace and successful? How long does SPL have to do further trial or withdraw current packaging if required ? Slow recruitment , less notiified covid etc will make a new trial even slower and harder to complete in age group unless a new strain starts to cause havoc and for instance in a hospital setting staff are required to test and report.
On another note you mentioned trials in regards to ethics . Look up Phoxwel trial . Link in one of my prior posts