A Netherlands start-up Vico Therapeutics could start clinical trials in late 2021 with its antisense approach to the treatment of rare neurological diseases, financed by its large Series A.

Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.

Wave’s Duchenne muscular dystrophy drug crashed, but Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

Agency officials can now discuss the ideas that have been accepted, though not in great detail.