Ann: Zeldas Autism Observational Study Recruits 100th Participant, page-13

My initial response when I read the announcement was lukewarm, as was the SP response. Phase 1 readout is not the big result we await with Insomnia RCT.

Key data in the announcement:

103 participants enrolled in the study, with the final target of 150 expected by early 2020.
103 participants enrolled in the study were using 76 different medicinal cannabis products.
Study identified marked differences in CBD and THC dosages between autism severity groups.
Analysis revealed key differences between these groups in terms of the doses and formulations of medicinal cannabis that were used.

And the important statement:

"Zelda is seeking to address this by using the outcomes from this study to inform the design of a randomised blinded clinical trial for autistic children, which is being planned for later this year."

The more I considered the announcement in the context of a Phase 1 trial, well it makes sense to assume:

1. Observations will inform the best CBD:THC combinations for each severity group in a planned RCT
2. Pharmacological testing has been performed (as per previous announcements)
3. Optimal blood levels of CBD:THC can be defined for each group (may never be published)
4. This information will inform the formulation of a product for the RCT planned to start late 2019 (patent pending)

I am surprised the company omitted any mention of pharmacological testing in this preliminary report of Phase 1 trial results. ZLD may never detail the exact pharmacological trial results, expect in filing for a new patent.... yet this is my reading between the lines.

I will be enthusiastic to see a patent approval for ZLD formulation / s for Autism