The FDA might have no choice... The FDA will give TLT treatment BTD(Breakthrough Designation) & AA (Accelerated Approval) only if the FDA see that there is a pressing need for TLT treatment.
Lert's see how the competition is doing...
1) BCG...
BCG is the standard of care, unfortunately there is a shortage of BCG.
https://discover.vumc.org/2021/02/bcg-shortages/will-persist/
As we speak regular patients are placed on a waiting list for BCG treatments, during that time there cancer could be progressing.
2) Keytruda...
Keytruda has a 41% CR at 12 months, unfortunately Keytruda has very bad side effects.
https://keytruda.com/side-effects/
(Quote) " Keytruda can cause your immune system to attack normal organs and sometimes become severe or life threatening and can lead to death".(End Of Quote)
Nothing more need to be said about Keytruda.
3) ImmunityBio...
ImmunityBio has a very good CR% of 71%/24 months(2022 numbers).
Unfortunately each patient need to start with 6 treatments in six weeks of BCG+N-803 and maintenence treatments of BCG+N-803 for up to 3 years.
That is a lot's of BCG treatment for just one patient.
Because of the shortage of BCG & the high number of BCG treatments needed for just one patient, the waiting list for the immunityBio patients could be very long, and by the time BCG become available the patient cancer could be progressing.
TLT treatment is a stand alone treatment.
The FDA might have no choice and see that TLT treatment doesn't need BCG, has no side effects and a CR% over 70%(could much higher for the optimised patients), all the above could be a very good reason for the FDA to give TLT treatment BTD & AA much faster than expected.