ImmunityBio Inc (IBRX)

[Spideyboy]

Just curious, having read this article from June 2022, what makes us think that they will get approval for Antikva.

My concern just stems from the bottom of the article stating.

"Other drugs are in late-stage trials in combination with BCG for the same patient population, including AstraZeneca’s Imfinzi (durvalumab) and Sesen Bio’s Vicinium (oportuzumab monatox). The FDA previously rejected Sesen Bio’s BLA for the treatment of BCG-unresponsive patients, citing multiple issues, including a lack of randomised data comparing Vicinium with an investigator’s choice of intravesical chemotherapy."
https://www.pharmaceutical-technology.com/analyst-comment/immunitybio-first-marketed-drug/?cf-view

There is no comparator in the Antikva trial with any intravesical chemotherapy either, or against anything for that matter. As it's open-label single arm trial, with only Antikva being used. Will this be enough for FDA approval?

I know the prior CRL didn't mention anything about this, but that doesn't mean it isn't a potential issue?

Looking to be convinced wrong on the above :)