If we set up a production facility and start trying to sell the insulin we produce, without going through the full regulatory process, we're in violation of the law. If we set up a production facility and give it away for free, and then ask for "donations" from the same group we give it away for free to, is that legal?

Jail may also be an overstatement. We are working with lawyers to get a clearer picture of the legal risk involved, for example maybe the biggest risk is that they just come shut us down.