Well I hope it goes well. But so far there is no information...

Well I hope it goes well. But so far there is no information that the expected OTAT meeting to review the potency assay has even been held, and if it has, whether or not it was successful.
After that SI intends to resubmit a BLA which may or may not be approved by the FDA.

I don't think it should be viewed as a foregone conclusion.

I will take time and money to go through the above steps. Meantime another trial which will easily take two years to complete is apparently being designed for low back pain. It may or may not achieve the primary endpoint. Anybody familiar with chronic pain trials and placebo responses knows the difficulties. I think investors should be cautious about the chances of success.

Given the performance of the company and its lack of both clinical trial and commercial success I think it is overvalued compared to other biotechs. It's only just trying to emerge from exploratory trials. Other major players have looked at investing in it and walked away after extensive scrutiny.