A Case Study on Drug & CDx Co-Development for Cutaneous T-cell Lymphoma
Time: 2:25 pm
day: Conference Day 1 PM
Details:
- Developing drug and CDx for CTCL in the US and Japan
- After conversations with the FDA and PMDA, it was agreed that CDx was not required therefore the drug was submitted for approval without CD
- Sharing key discussions with the regulatory authorities in agreement and lessons learned to inform future pipelines
