If not that FDA adding different requests every 2-3 months , and finally October 2020 they asked for ROT for BLA , not only from combo patients but from all over 500 patients in mono , which is a ridiculous request , not needed , only to delay. There is NO OTHER reason...
No doctor will order this test for combo if patient is on 700 mg of leronlimab , why would they,..
Why the sudden need for ROT in combo , and why they asked close to 3 years after study were finished ...there is NOTHING reasonable here..
All IMO.
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