Huma submitted a BLA with priority review which was suppose to be completed Aug 9th but was announced more time was needed and so extended.
Based on previous drug extensions the average time to approval was 3 months on the day extension was announced. So Aug 9 - Nov 9. Since it's a weekend it will be approved the following week as long as theirs no issues (CRL).
Some drugs that received extensions and approvals:
Nirogacestat - AUG27/NOV27
Palopegteriparatide - MAY 14/AUG14
Arimoclomol - June21/Sept21
Aducanumab - Mar7/June7
The list goes on. I have bought 300 x Nov15 7.5 Calls.
This is entertainment like your mom.