I compare the difficulties in filing the BLA to difficulties lawyers have when they file papers extensive papers with a court clerk. Some clerks are persnickety ( a word I saw in a dictionary today and was determined to use) and some are hacuna matada. With the former, a face to face meeting resolves 99% of the issues, or at least sets the road map for resolving the issues.. I expect that to happen during the A conference with the FDA.