CytoSorbents Corporation (CTSO)

[biotech48]

pearsby, you are spreading misinformation again, as usual. All that you have to do is read JoelY's post below for the correct information that was published by CTSO on May 24, 2017. Also as JoelY stated, if data is overwhelming, the trial can be ended early.

• REFRESH 2 is expected to be similar in design to REFRESH 1, but with a more focused target population that accounts for more than half of all complex cardiac surgeries that demonstrated the
highest levels of pfHb and are at greatest risk for organ injury
• Preliminary trial design, pending discussions with the FDA:
– Plan to start with core sites from REFRESH 1
– 300-500 patient, 30-40 center randomized, controlled PMA trial
– Primary clinical and cost-effectiveness endpoints: Progression to acute kidney injury (AKI),
incidence of stroke, time on mechanical ventilation, hemodynamic stability, days in the ICU
– 2 year expected duration at 0.5 patients/month/site
– $10-12M cost spread out over 3 years – potential for strategic partner support
– Targeting 1H 2019 enrolled, 2H 2019 data, 2020 targeted approval