It may be that they have the formulation done but it's

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

Quote:

with plans to package it in an easily transportable sachet form

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.