He also has to argue that due to the nature of flu seasons,...

He also has to argue that due to the nature of flu seasons, there is a real risk he may not even get >100 additional PCR+ patients in the next Southern Hemisphere flu, if its a mild season.

The question needs to be asked of BARDA, do they want this drug available sooner rather than later? They had hundreds of clinics over 2 flu seasons, one being a moderately strong season and we still struggled to meet enrolment targets.

As RP says, lani has been used by 7 million people in Japan (now probably 9 million), and clinical trials have proven to reduce viral shedding (which should be important info for the FDA, regardless whether they recognise non-inferiority trials).