Depends on how you define efficacy. Guessing hitting a primary...

Depends on how you define efficacy. Guessing hitting a primary end point ("statistical significance") doesnt count if there are potency assay issues? Sure i guess... but FDA have not suggested the trial has failed in the way you are suggesting it has ("no statistical significance") even though previously you were going by the great southoz playbook ("who you would do well to listen to" etc, in conjunction with lassman law and co...) that set out reams of dialogue about confounding items regarding the control arm and treatment arms etc etc. And it seems like that's been put to rest hey? Oh but they simply havent mentioned that stuff so its probably still some uncertainty capital to throw around on that while there is still money to be made going short...