MSB 2022 - The road to commercialisation, page-1043

Unfortunately when you read that it reveals what a disaster the potency issue has turned out to be. Far from supporting the company's claim about having developed an assay that supported SI's narrative of "a well defined mechanism of action" it turned out to be nothing of the sort. It didn't actually work or it didn't support the trial results. Hence the delays while they furiously tried to create an assay by working backwards from the trial results to find something that might correlate. But I would suggest that it still isn't very good and the new emphasis on "the totality" of the evidence and the panel opinion points to a more shakey submission than one based on on hard evidence from a conclusive potency assay thar supports the data. I wouldn't be surprised now if there are more delays to the submission or the BLA is eventually withdrawn or rejected.