Exactly PB,
Where have you been? We haven’t heard from you in ages! At present the trial will focus on patients who have relapsed with Auto CAR-T. The Black Box warning is a serious one, but it doesn’t mean that the benefits outweigh the risks, especially for Cancer patients. They need to be aware, and that is on top of some potentially life-threatening side effects. It would be negligent of the FDA not to do this.
As things progress, hopefully there are safer options incoming with Allogenic CAR-T. If everything works to plan & we get a Registrational Ph2 trial with Azer-Cel up & running this year, then patients will have more choice, & from data we have discussed already, a safer & more convenient choice, including more timely treatment.
Happy Long Weekend & Straya Day Everyone.
Media Thread, page-11492
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