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Doc, it might be best to filter Oak as I now have. We don't want the board taken over by a personal spat.
Spin
Doc, Cheers for the advice but why would I not laugh at your posts? Have I Got News For You is only on once a week.
Last word syndrome. Watch
mattw007 - I should’ve added context to what I meant. My reasoning is that they have higher hopes for SNG001 to be safe and potentially efficacious in lower risk people.
I do agree with you that should SNG001 is be removed due no benefit in lower risk people then it’d be ridiculous.
Spin - I interpreted his words in the context of what the protocol states as I knew we were not just for lower risk patients. But, of course it’s possible that in practice the higher risk are ‘naturally’ given to I/V if that decision is left to a human.
However, isn’t it an algorithm which decides who gets which agent?
4 out of 5 most vaccinated countries are seeing increases in coronavirus cases. Source Forbes.
Off topic but I wish Oak and Doc, would shake hands.
Matterhorn, Yes I was sure I read in the protocol that an algorithm selects the drug.
Don't get too hung up on efficacy in P2 of Activ-2. The drug will show safety and in all likelihood will reduce viral loads and that should be enough to get it through to P3. 200 patients is not enough to show efficacy for any drug on a measure of hospitalisation/death with the cohort being investigated. P3 is going to recruit 1000 patients which will give the drug a chance to show efficacy even in milder cases. Those patients are going to take around 12 months to recruit unless the trial rolls out on a large scale internationally or the US experiences another severe wave. The hospital P3 will be done and dusted by then and the drug should have full approval if data comes up as expected.
Activ 2 (operation warp speed) P2/P3 progression may still provide the opportunity for early EUA however, but does not seem to have the same significance that it has in depths of last winter.
ACTIV-2 protocol summary says, “ The study includes both infused and non-infused agents. For infused agents, enrollment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both "higher" and "lower" risk of progression to severe COVID-19”
Matterhorn
I also think I read something like that in the protocol. Ie it would be an algorithm or randomised but nevertheless if most of the patients are not very ill and they can't be given I/V or injections, the chances are that there won't be many people in the SNG trial who are displaying severe symptoms. I did think at the time when I read the protocol that they would have to either decide to either give a fair proportion of the severe patients the non-invasive treatments or equalise numbers on the trials. They obviously could not do both. In the former case the two non-invasive trials would fill up much more quickly than the others. This does not seem to be the case. Therefore I surmise that they are equalising numbers in each trial and this would automatically mean that a very high proportion of the cases treated with SNG001 would not be very ill.
Best Spin
Just saw Bryosa's extract.
Please substitute 'lower risk of progression' for my 'not very ill' and vice versa.
Thanks Spin
I’m sure in any review the teams will adjust their expectations in line with the protocol. The bar will undoubtedly be lower and we know from our own study that even in that situation we showed a threefold improvement in a sub group of that population
1 week ago now, not long to wait for Activ 2 results, perhaps as soon as next week!