Market PotentialNiyad's potential advantages over other anticoagulants in dialysis create a positive outlook for its market potential.
Regulatory ProgressThe FDA agreed to review the PAS submission to enable formal amendments to the study protocol, indicating regulatory support for Talphera's plans.
Study ExpansionTalphera has received FDA approval to increase the maximum number of study sites to 14 from 10, which is expected to help expedite the planned enrollment of 166 patients toward completion of the study.