RE:RE:Anonymous still applying pressure to SVA, why??you are correct in that the sentinel pouch will be removed and stained at 90 days and that will be used in the clinical trial, as set up, as an indicator of islet survival as an interim indicator of efficacy.
however to me the true measure of efficacy is are the islets not only surviving but doing their thing and measuring the glucose level that they see and further doing their thing in producing just the right amount of insulin to keep the glucose level in the blood at an optimal level.
I do not think they will overproduce insulin and bring the glucose level below where it should be but i see the medical personnel monitoring the glucose level regularly and to me they will see efficacy when the engraftment has actually taken place and the islets start actually producing insulin.
in mechanical insulin pumps there can be release of too much insulin; but i believe the islets do not have it in them to produce too much but again I believe the medical persons must keep a very close watch on glucose levels. their self modulation of the levels is the true measure of efficacy in my opinion.