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@Bazsa, I agree with everything you say except at the end. The current trial is to evaluate remestemcel-L as a treatment specifically for the ARDS of Covid-19. It's possible to have ARDS from a variety of other causes, both infectious and non-infectious. But to get into the rem-L trial a patient must have evidence of infection with the virus that causes Covid-19. So in these Covid-19 cases the ARDS is a manifestation of a more severe form of the disease, next stop multi-organ failure / death. Remestemcel-L may be useful for some of the other causes of non-C-19 ARDS. That will be worked out through clinical experience and perhaps additional clinical trials down the road.

Inclusion Criteria

• 18 years or older
• Patient has coronavirus disease COVID-19 confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test

• Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria)

  • Bilateral opacities must be present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
  • Respiratory failure not fully explained by cardiac failure or fluid overload.
  • Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
• Moderate ARDS: PaO2/FiO2 >100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR
• Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O
• High sensitivity C-Reactive Protein (hs-CRP) serum level >4.0 mg/dL
• Acute Physiologic and Chronic Health Evaluation (APACHE IV) score >5
• The patient or his/her legally authorized representative (LAR) is able to provide informed consent