"Received an IRB approval for a Phase I, d
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Posted On: 04/20/2017 9:21:15 AM
"Received an IRB approval for a Phase I, double blind,
randomized, placebo controlled, multiple escalating dose study to determine the safety,
tolerability and pharmacokinetic profile of medical grade cannabis in healthy volunteers.
The study should begin in or about April 2017." 10K page 6. Look at the 10K for 2015. Literally says the same thing except for the bolded part.
Phase I, i.e., safety, hasn't started yet. That means the cream is years away from FDA approval. They will need to do Phase II and Phase III next which will take time and will cost millions.
randomized, placebo controlled, multiple escalating dose study to determine the safety,
tolerability and pharmacokinetic profile of medical grade cannabis in healthy volunteers.
The study should begin in or about April 2017." 10K page 6. Look at the 10K for 2015. Literally says the same thing except for the bolded part.
Phase I, i.e., safety, hasn't started yet. That means the cream is years away from FDA approval. They will need to do Phase II and Phase III next which will take time and will cost millions.
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