Ann: MSB Q1 Financial Results and Operational Highlights, page-109

I haven't had the time to go back and listen to the whole thing, but this is the Q and A I was talking about:

Analyst with RBC Capital Markets:

I just want to, I just want to confirm. I had heard right, so you will meet with the FDA in December to address the potency/assays. And then once assuming it's all resolved, for that ARDS trial, you can just go ahead and initiate a phase 3 without meeting with the FDA again, right?

Silviu Itescu:

That's exactly right. We have we have a discussion with the agency in very short order about potency assays for the product, we expect that they will be comfortable with the data that we're putting in front of them, at that point the clinical group will move forward with an IND proposal for a pivotal trial.