Comment from CDKL5 in Color

Summary: CDKL5 in Color, a patient advocacy organization for CDKL5 Deficiency Disorder, expresses enthusiastic support for the Haystack Project citizen petition. They argue that the current FDA drug approval framework creates insurmountable barriers for ultra-rare diseases and advocate for the adoption of Bayesian adaptive designs, biomarker-stratified enrichment, and formal early-stage consultation with patient experts.