Cytodyn Inc (CYDY)

[Scooter McCabe]

The Cherry Picking Of Lenzilumab

The devil is always in the details. If you go Exclusion Criteria:

Confirmed diagnosis of ARDS
Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline

Known medical history of tuberculosis or a risk for tuberculosis exposure

Known history of hepatitis A, hepatitis B, hepatitis C or HIV infection

History of pulmonary alveolar proteinosis (PAP)

Requiring invasive mechanical ventilation upon hospitalization prior to randomization

Women of childbearing potential who are pregnant or breastfeeding

Known hypersensitivity to lenzilumab or any of its components

Use of anti-IL-6 therapy or any other potent immunomodulatory or
immunosuppressive therapy or live vaccine within 8 weeks of
randomization (corticosteroid use is permitted)

Use of GM-CSF agents (e.g., sargramostim) within prior 2 months of randomization

Expected survival < 24h in the opinion of the investigator
Patient > 85 years of age

Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study

What they have done is effectively narrowed the study to avoid having to report safety complications as much as possible. The danger of a study this narrow is that it does not reflect how it will actually be applied in the real world. That or it is only available to a narrow field of patients due to an incomplete safety profile.