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Friday, May 25, 2018 12:02:43 PM
Initially submit an IDE application to the FDA.
Select Investigators qualified by training and experience.
Select Monitors qualified by training and experience.
Submit changes to the investigational plan to the FDA throughout the study.
Ensure the Investigators are compliant with the agreement, protocol
Report Unanticipated adverse device effects
Maintain accurate, complete and current records.
Submit reports regularly within the required time frames to the FDA.
So again Ziv had plenty to keep him busy and as we all know now he was over his head. Whether the delay was just pure inexperience or actual participant dropouts we may never know. Either way it does not matter to me because I am extremely confident the team we have in place will get the job done. A team of this caliber will transform us into a leading cannabis research an development powerhouse (assuming we don't get bought out first.) Have a great day.
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