Tuesday, July 25, 2017 1:57:00 AM
Of course, it might take longer, but at least the potential is there for a PR on approval in Kenya.
Here is the relevant part from the PR on April 25th:
"The PPB had a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. “The application was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distribution agreement,” concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017."
This time she did not claim to have orders already lined up, but she does say commercialization yet this year!
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