Hi Titans,
I'm not sure exactly what you're asking, but allow me to respond with what I think may be helpful.
As per the diagram at the end of the announcement, the primary endpoint is the reduction in nasal viral load (i.e., shedding) of SARS-CoV-2 compared with a placebo nasal spray (coloured water).
This is the second COVID study we have completed with Nasodine. The first was a pilot study in 6 subjects who were culture-positive for the virus (publication: https://www.theajo.com/article/view/4466/html). That study showed that a single dose of Nasodine can substantially reduce the amount of detectable SARS-CoV-2 virus for up to one hour after the dose. It was a small pilot study, there was no placebo control and there was no "primary endpoint [that] was not met."
The current (closed today) COVID study was designed to show that multiples doses over several days would dramatically reduce the viral load and potentially even eliminate it (compared with placebo). This is a randomised, placebo-controlled trial with a clear primary endpoint.
I suspect your reference to the primary endpoint not being met previously, refers to the results our first Phase 3 study of Nasodine as a treatment for the common cold (completed 2019), where we missed the primary endpoint, but still demonstrated clinical efficacy - although we are still trying to convince TGA of that fact (refer to our AAT appeal announcements).
The common cold obviously is a different indication to COVID-19, but importantly in a common cold study, there are no objective endpoints (such as viral load). The primary endpoint in a common cold study is based on subjective reporting of symptoms, something which is compounded by a large placebo effect in the common cold. We are now completing a second common cold study that we expect will confirm Nasodine's efficacy in that indication, despite the challenges around subjectivity and placebo effect.
In summary, for the COVID-19 study, we are dealing with an objective primary endpoint that is not affected by subjectivity or placebo effect. That is why we can be confident that even a small cohort of subjects should deliver significant results.
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Hi Titans,I'm not sure exactly what you're asking, but allow me...
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