GILD gets clinical hold lifted quickly after a pat
Post# of 148280
(Total Views: 713)
Posted On: 08/30/2023 9:51:49 AM
GILD gets clinical hold lifted quickly after a patient death. So, Big Pharma kills someone, clinical hold is "very short." Small company CYDY gets put on hold for very long time for.... why?
Quote:
Gilead Sciences' $225 million bet on Arcellx’s CAR-T cell therapy is back in play after the FDA lifted a clinical hold instigated in the wake of a patient death.
The trial pause has been very short , with the regulator only implementing the hold on the iMMagine-1 study in June. At the time, Arcellx said it believed a contributing factor in the fatality had been “limitations on bridging therapy,” a term for the treatments given in the period between the T cells being removed from a patient’s body and the CAR-T being infused.
https://www.fiercebiotech.com/biotech/fda-lif...ient-death
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