RE:SVAWell I have seen the incredible time taken to get FDA approval to go from the preclinical stage to the clinic.
I have been here for a number of years and I have believed in the company's functionality of its product and as far as I am concerned the pouch has been shown to work properly.
unfortunately I also understand why the move to the clink with the pouch and cadaver sourced cells has required potential patients for whom the benefits of process outweighed the cost of anti rejection medicines (money cost is relatively low but the destruction of the immune is terrible in my opinion)
the only people in the phase 1/2 are only people for whom their diabetes hypoglycemia means they might die if their injected insulin causes them to go into a coma and die in their coma.
now we get to the next stage of the big step of using cells grown through artificial stem cell processes which also require defeat of the immune system to keep it from killing them.
this potential step requires local protection such as the conformal coating, as well as the use of stem cells produced in a lab.
unless the stem sells can be used there is a severe shortage of cadaver cells.
the sum and substance of the situation is the heavy time required to put these pieces (which look good in pre clinical into an FDA approved clinical process and getting approval.
the potential of an FDA approved process to a Practical Cure is such that we can dream of the benefit to humanity and the benefit to ourselves as shareholders.