RE: Phase 2 study16 Dec 2020 20:00
Boyg,
That’s a pretty unusual statement. You do understand you can get a statistically significant result from that sample size? A statistically significant result would indicate that the observed effect is not down to chance. The phase 2 trial had a number of results that were statistically significant. So the number of 48 is meaningless unless put in context. N =48 with no statistical significance would not justify approval of course, and maybe N =48 with significant result but no other evidence doesn’t deserve approval either as cohort is too small.
However if you combine this result with the following:
Safety: 250 odd patients that have taken this drug and it has been proven safe over 3 phase 2 trials over many years.
Interferons: evidence that interferon response, or lack thereof, is one of the reasons that covid is causing havoc and killing a proportion of those infected with covid.
Now as a governing agency who is put in charge to protect the health of a nation, in the middle of the worst pandemic in 100 years, does the potential benefit of using an interferon based drug that has statistically proven 79% efficacy with no obvious safety issues outweigh the risk of using such drug.
It is funny that all vaccines have been authorised on this basis ie. the benefits of taking the vaccine outweigh the risk. At present we don’t really know the long term benefit and as we have seen there are risks for certain people being vaccinated.
IMO at this stage of the pandemic the benefit of using SNG001 far outweighs the risks based on more than just the phase 2 efficacy and it really is a travesty that the MHRA and other governing bodies appear not to be assessing risk/benefit it in this way.