Sad but timely reminder that it is serendipitous that the company has moved past the stage when what it is doing is dependent on knowing the right people in the FDA. I know it sounds surprising, but if you are in the last mile with “general alignmemt” with the agency on the things that count in a cell therapy discussion on BLA submission, such as CMC matters and trial design, you are likely not unclear about the details, which in a regulatory context are way past the buy in you need to get from the people at the top.
So I am not worried at all. The momentum remains, and it can be reasonably inferred that the company should continue to gather further speed in the next little while.
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