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rosie77

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rosie77

Re: Rawnoc post# 103502

Friday, 11/07/2014 4:25:04 PM

Friday, November 07, 2014 4:25:04 PM

Post# of 146240
LOL, you do realize there is a difference between cGMP and cGMP-like? As stated, cGMP-like is required for human trials, full cGMP certification comes later.

Scale up production in the new facility = 2015 at best. Then another 9 to 12 months before cGMP production capability. After both of those, they have to produce enough for human trials.




"Phase I drug testing to begin after the IND filing, and requires availability of cGMP-like manufactured product. The cGMP production capability is expected to achieved in 9 to 12 months After we begin scale up production in the new facility."

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