Lol. Ok. You must not have read the 10Q then. I didn't say anything about what is and isn't fda required. I repeated what was in the 10Q and it says
We are continuing to work on projects related to the planned IND submission... a container closure integrity test of our clinical trial product that will be conducted over the course of two years, a pyrogenicity test, preparation of the angiography guidelines for implantation of the encapsulated cells for use in the LAPC clinical trial and a two-year stability study of our clinical trial product
So the 10Q says the two year tests are part of IND submission right there in black and white. LOLOLOLOL!!!! For those who can read lol.