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Re: MjMilo post# 140474

Friday, 05/25/2018 12:02:43 PM

Friday, May 25, 2018 12:02:43 PM

Post# of 203913
Sorry about just getting back to your response. We are on the same team here and to refer to some of my post as garbage is rather rude. Repeat we are on the same side. To respond to you criticism, I never said Ziv was the reason the trial is late, just giving another possibility. Ziv had a ton of responsibility in assuring the clinical trial went smoothly. One World Cannabis is the sponsor of the trial and Ziv was the CEO. The responsibilities of the sponsor are vast and here is a list of just a few of the responsibilities. Keep in mind just one misstep can derail a trial and the biggest and most costly misstep that happens regularly with new companies is selecting the right investigator, things can get ugly quickly.

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.