The old stuff comment was claretjay. Your stuff I expected info on sales not a brochure. Just hacked off with permanent ramping attempts based on straw
No you are missing the point. That date was their legal obligation. The query is whether in this and other cases they issued a crl to kick the can down the road because they had not covered all the bases within the deadline due to resources constraints. You may or may not agree with that but that is the point raised in some Us commentary on fda and crls
Ps as an ex auditor I recall you don’t need that big a sample to get to 95 p c c l so it could be relatively little extra work if new sample needed though I suppose you have to find relevant bods for the trial ?