They say there were no SAEs attributable to lenzil
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Posted On: 09/09/2021 11:53:17 AM
They say there were no SAEs attributable to lenzilumab. Although lenzilumab is an immunosuppressant. I think they were turned down because of lack of benefit. Their p value was p=0.0365 but they had changed endpoints. It could be that the FDA thought the p value was not valid.
The FDA says they will look at additional data and HGEN is pinning their hopes on the Activ5 trial. HGEN's trial was for severe/critical patients, Activ5 is for moderate to critical. HGEN's primary endpoint is Ventilator-free Survival, Activ5's primary endpoint is Time to ventilation or death in subjects with a baseline score of 5 or 6. The inclusion of moderate would not be beneficial to HGEN. The saving grace is that the control arm consists of remdesivir with placebo. Although that they use remdesivir only in any patients above mild ensuring a death sentence for many is criminal.
The FDA says they will look at additional data and HGEN is pinning their hopes on the Activ5 trial. HGEN's trial was for severe/critical patients, Activ5 is for moderate to critical. HGEN's primary endpoint is Ventilator-free Survival, Activ5's primary endpoint is Time to ventilation or death in subjects with a baseline score of 5 or 6. The inclusion of moderate would not be beneficial to HGEN. The saving grace is that the control arm consists of remdesivir with placebo. Although that they use remdesivir only in any patients above mild ensuring a death sentence for many is criminal.
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