That’s not quite the plan we’ve got planned for the project. We share your concern for questions of safety and ethics so we are only trying to accomplish a proof of concept right now.
The goal is first to make normal human insulin using methods broadly similar to those used already, but keeping the information needed to do so open, avoiding proprietary restrictions on the work, and trying to take opportunities to keep things as simple, inexpensive, and easy to reproduce as possible. If we succeed on any of those points, we would then hope that an existing generics manufacturer might be interested in taking up the work to bring a generic version to market, and we would try to partner with one to do the necessary work to ensure purity and safety. The general regulatory rubric this would fall under is the biosimilar regime, which is mid-way between the rigor required in vetting an entirely new drug and that required of a copy of an old one made with strictly chemical means. This was the plan we outlined in our original crowdfunding pitch and remains our current thinking.
We’d welcome funding from the NIH or another large funding organization if they’d have us but, among many other reasons to be skeptical about such a prospect, I doubt there would be enough that’s novel about our work to qualify it as fundable science.