Ann: S3 Trial update, page-25

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FiSaver

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20/01/23

12:37

Post #: 65793856
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Originally posted by Anna9828: ↑

I disagree. The trials for CBD for sleep, at doses under 100mg have been completed for a few years now with not great results. All they had to do was a sufficient literature search to see that. Anyone who has been in the industry for a few years could have predicted this result. If their point of the study was to support registration then they wasted their time and money on a bad design. Period. And yes, I brought this up when the study protocol was first announced, just not in the Hot Copper forums. These companies who are serious about S3 registration need to go with 100, 150, 250, and maybe even 400mg to test the results for Plan B: prescription registration (rather than Over the Counter). I am still hopeful that 150mg (max daily dose allowed for the S3 OTC space) will be effective. Unfortunately, this has not been tested with a proper RCT study by anyone yet, which baffles my mind, considering it's the dose that has been earmarked by the TGA for registration, public for over two years now. And with the risk of it not being effective for sleep at this dose, they may as well include a dose that would be okay for S4 as a Plan B. Drug development is not really that difficult, if you DYOR and assess the published results. In the end, perhaps S3 OTC will not work for sleep/insomnia. Then the green companies will need to find an alternative indication. Or go for S4. Wish they would just pay attention.

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while all true it's the regulatory and eithics bodies that you have to work in. you might say I want to do 400mg (which isn't within the S3 limit of 150mg)

and they say show me 100mg first. low dose. then I will allow larger dose. that's what we have experienced so far. the whole lot and slow. ramping up.

Last edited by FiSaver: 20/01/23

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