RE: Phase 2 study16 Dec 2020 21:18
The boyg. "I would never authorise a drug to the world based on 48 results"
In an ordinary world I would agree following traditional clinical regulation global rules. This would be the absolute way to go for most new medicines in our prior "normal" world. However, and this is a big however, we are NOT in an ordinary world from 2020 + onwards with the fight against covid so your so called normal best practice regulatory methods for regulatory approvals are no longer fit for purpose. Everyone needs to evolve their old thinking and paradigms to catch up with the new normal. We need pragmatic, new risk/benefit based clinical decisions to help get us all out of this big global mess;
My two observations for urgent emergency approval for SNG001 following the excellent phase 2 result are as follows (by the way I'm amazed we did not get emergency approval by September):
1. I'm right I think to say the "small"phase 2 study showed massive statistically significant differences in deaths and reduced disease severity progression/ hospitalisation days...so with purely my statisticians hat on that means we can have confidence that, say, around 95 times out of 100 these results will be reproduced on a larger sample. Excellent! And if it turns out that in the unlikely event with a 5% chance we are unfortunate enough NOT to get the desired phase 2 efficacy result reproduced (by chance) then we tried and gained nothing. But the important issue here is that we also have LOST nothing either if we were to approval SNG001 because the safety of SNG001 appears very very low in a much bigger statistically significant way due to all the prior patient observations over many years and background use of INF for MS which arguably is much more risky being injected than nebulizer to lungs. Am I right here or am I talking b*llocks? E.G. 95% chance of great success for SNG001 efficacy with much lower deaths and hospitalisations v's 5% chance of no clinical benefit at all with no real safety risk to patients.
2. Thinking like Darwin; The virus being an RNA based virus mutates and evolves (ie. natural selection or a bit like evolutionary learning); More rapidly in fact than can be said for the human brain which due to its great neuronal complexity and based on its past successes in evolutionary and environmental performance terms is unable and incapable to think on its feet or indeed "out of the box" and to evolve at the same pace as this tiny pathetic pathogen. How sad, the human brain gains comfort to select and adopt prior thinking processes with "tried and tested" decision frameworks and appears to gain comfort from familiarity and box checking as if like some sort of comfort blanket....oh dear I do think this could be the beginning of the end for a very advanced organism on this planet! Us. If this virus had a brain and could think, I'm sure it would be cracking jokes similar to the ones in the "for mash get smash" advert from the late 70s with th
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