I agree and outside of a country issuing an EUA or some
I agree and outside of a country issuing an EUA or some deal to purchase 100,000 vials+ for CSP/IO or similar interim sales, this large powered trial is the best thing we could hope for (especially given the partnership with such a prestigious ARO and a country in dire need).......but like Craig and many others wish that leronlimab was saving thousands of lives already. Unfortunately this isn't an option at the moment for Brazil and likely other developed countries that are following the lead of the US FDA.
While I hope that interim results will be sooner than outlined, we don't yet know when the protocol will be finalized, when the trial will actually begin and how many sites will be enrolling or when more will begin recruiting. I expect the protocol to be much better than CD12, so there is a high probability of hitting stat significant p-value during interim analysis (CD12 was stat significant with 2 injections and N=62, so 4 injections and N=120, seems likely to hit it out of the park). The other positive thing for us investors with this trial is it begins the clock for what should be an EUA or approval for COVID and as the days count down to interim results, the share price should appreciate in anticipation similar to CD12 did in late 2020 and early 2021. I expect continued stock manipulation until we get other positive news or results, but at least a new trial is moving forward and can't ask for anything more from CYDY or Brazil other than issue a EUA, fast enrollment and many trial sites recruiting.
One last note, I am glad to see that severe is also being pursued. While it may not be as promising as critical, it is likely better than most other treatment options currently available, may keep some from advancing to critical (real life impacts) and if it shows even clinical significant results, will likely be used by treating physicians and increase sales exponentially when the day comes.
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