It may be that they have the formulation done bu

It may be that they have the formulation done but it's not actually packaged yet --

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with plans to package it in an easily transportable sachet form

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or maybe they have the formulation completed but manufacturing hasn't been started until they were sure the FDA would let them go ahead. As I think about it, that would be smart, why commit the money until you know if and when it's needed.