KK they will be lining up - insomnia and anxiety are an unmet need ....globally...
to ensure all the recruited for the trial meet the 'chronic sufferer ' classification for both placebo and treatment arms across a large and therefore statistically significant differentiation will delineate between success or failure to meet endpoint outcomes successfully.
Understanding the prevalence and criteria of chronic insomnia and the comorbidities that accompany it is key to successful recruitment and treatment outcome....patient cohort size is key hence the 500+ on this trial. recruiting from that particular demographic clearly represented in the .prevalence' data is key -
'Various studies worldwide have shown the prevalence of insomnia in 10%–30% of the population, some even as high as 50%–60%. It is common in older adults, females, and people with medical and mental ill health.[4,5,6] The consequences of insomnia are significant, such as depression, impaired work performance, work- related/motor vehicle accidents, and overall poor quality of life. It is an easy-to-diagnose condition with many self-answerable questionnaires for aid, yet goes unrecognized in a significant number of patients coming to the outpatient department with other comorbid conditions. The objective of this study was to determine the prevalence of chronic insomnia, to look for any association with socioeconomic factors and medical comorbidities, and also to assess the patient's perception of having insomnia.'
mate we are not talking about the odd restless nights sleep here - we are talking unmet need with comorbidities that sit vacant in the Sched.3 treatment space - first mover will achieve market leverage in the space and attract BP for a red hot go...let alone achieve quality of life outcomes never before realised in that particular treatment titration for relief in the chronic cohort.
Anxiety is the moat
this is far from a 'Blackmores' off the shelf condiment
the numbers are correct on the skinny data available ....the real data as posted as an example by HT a few days back
Red or Black if your game for it
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