I understand and appreciate your point, but Joe and Rich discussed the CMS and GMP manufacturing in depth during the last CC. So much in depth I tried rewriting it for everyone here in what I hoped was an easier to understand fashion. Also the last press release noted:

Joseph Moscato, President & CEO of Generex stated, “We are preparing our IND submission for Phase I and II human clinical trials to evaluate safety and immunogenicity of the Ii-Key vaccine, and plan to submit the IND to the FDA as soon as the GMP production of the Ii-Key vaccine is completed in the coming weeks.