Item 8.01 Other Events.

The Company has updated its clinical development milestones.

The Company is in the process of completing the requirements to answer regulatory questions and begin the re-submission process in the US. In addition, the Company is submitting appropriate filing in Europe to commence a Phase I/IIa trial at a major CRO site in Germany which we anticipate will commence in Q3 2022.

The Company will provide further updates to its clinical development schedule as it becomes clearer.





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