Thanks to this document I think I have a better understanding of what the issue is with the BLA, (so much for "mislabeling" of syringes). This letter looks like a concrete step in righting the ship regarding the BLA. Mixed metaphors aside.
The problem is you don't know what you don't know.
What other issues might there be with the BLA? I was under the impression that the BLA would be submitted before the end of the year. I wonder if that is still accurate.
It might be helpful if someone could itemize each issue that has been blamed for the RTF and delay of filing for the BLA and the progress that has been made on each of the listed issues.