BLA- I agree 100%. He can't announce "it" will be

BLA- I agree 100%. He can't announce "it" will be filed again even with a guarantee. Only announce when it is filed. I too believe it will get done but only announce when it is filed! Delays are business as usual with FDA even for BPs. The fact BLA has been delayed several times is not surprising especially with small team not to mention the team now working night and day on covid.... I do realize our manufacturing partners are mostly responsible for the manufacturing portion but we want to make sure all is submitted correctly and what FDA wants to see. And again this unfortunately is BAU - business as usual...