'LilKahuna'those requirements are going to handcuff LEO if he doesn't start hiring people who are familiar with process. A 3 man operation ain't gonna cut it. imo
"When sponsors receive an expedited drug development designation, they should be prepared to propose a commercial manufacturing program that will ensure availability of quality product at the time of approval. The proposal should consider estimated market demand and the commercial manufacturing development plan."
This should alleviate the questions around the current dilution.