Cel Sci Corporation (CVM)

[sab63090]

FDA's Janet Woodcock:

Woodcock voiced particular frustration with the way the booming immuno-oncology field handles trials. Notes Porges: “For example, she suggested they have primarily been used as dictated by the protocols of the original trials, but wondered if these agents that affect the immune system would be better used with upfront or intermittent dosing. She also expressed concern that adequate biomarkers and the time to onset of response is poorly understood. Finally, she opined that it is unclear whether all of the PD-[L]1 agents are truly different or just various iterations of each other. However, the FDA does not have the ability to answer these questions, many of which could reduce the value of these assets, without the buy in from industry.”


https://endpts.com/the-fdas-janet-woodcock-talks-about-some-big-changes-shes-pushing-for-in-drug-development-and-agency-reviews/