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eicoman

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eicoman

Re: eicoman post# 27495

Saturday, 01/13/2018 8:32:00 AM

Saturday, January 13, 2018 8:32:00 AM

Post# of 30351
After the Nov 2016 Type B meeting the FDA asked for the Human Factors Device study, which caused a delay, but at that time they did not ask for any other studies, so it looks like Apri has met all of the requirements of the FDA CRL with a very strong package, backed by approvals and safety studies from 29 other countries.
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