The RPE program is our core development effort. We have attempted to provide public updates when there is a significant event surrounding that program that changes the situation from our previous disclosure. We have stated that we are in continuous dialogue with the FDA as they evaluate our initial IND submission and any subsequent data that has been supplied to them. If there is a change in status, the company will immediately inform the public. I think it is safe to assume that no news means no change.
Thanks for the post. Although this is not good news we are just waiting. It removes the doubt in my mind, we have been turned down and are hiding it. Simple honesty removes the herd mentality fear. I will continue to hold for now.
Maybe a little conspiratorial but I think the hold on anything that involves stem cells is sort of like an earlier commenter said it will take a while to see who will be paid off. Some of these new therapies could be game changers and the powers that be (big pharma) need time to plan it out so they reap most of the rewards. Since the FDA and politicians dance to their tune they will be the ones to call the shots. The big guys always win.
Back in Germany I loved to watch a TV series named: " Now it is my turn to speak "
And so they spoke and the normal BS continued no matter who spoke.
Now I speak!!!!!
FDA TAKE YOUR DARN FOOT OF THE BRAKE, WE WONNA GET ROLLING.
Oh by the way, I think Caldwell spoke well, we just have to add another two month before we get excited again. Things have to "mature". Lots of things mature at the FDA. I often compare Biotech with large development projects in the building industrie. They figure 10 years the plans have to "mature" before a permit is issued... and all concerns are paid off.