We need BLA submission now that...the FDA required process checks are 100% completed from the postings of the pumpers. The completion of the analytical assay was prior to Sept 30, 2019 (Q3).
What is the hold up? The paper work was done two years ago while waiting for the final piece of the puzzle which was completed prior to Sept 30.
Seriously, it is now more than six months to complete the paper work of which most was done already. Six months! Newcamo IDs have constantly said paper work would be completed quickly and submitted to FDA. Six months and counting is not quick.
Which shoe dropped this time?