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Rockleo

09/23/20 5:20 AM

#118525 RE: Midnight-Rider #118383

Midnight-Rider..Interesting question..How should we do the Long Hauler Trial..??

BY NOT REINVENTING THE WHEEL...

We have a Group of 86 Mild to Moderate...AND...195 Severe to Critical patients who have received Leronlimab..OR..a placebo in the last 5 months.. !!!

Take a look at the Primary and Secondary End points..in OUR protocol to be submitted to the FDA ..next week..for the Long Hauler Trial we’ve requested..!!!

Make a Questionnaire of these 15-16 symptoms..Have Grip it and Rip it do something useful..For a change..!!! Have him do a telephonic interview with these 86 + 195 = 281 patient’s.. in a blinded fashion..Where he is NOT aware of who got Leronlimab and who the placebo..

Tabulate the responses..!!!

This MAY give us a Treasure Trove of information..Shortness of Breath..Brain Fog..Fatigue..Myalgias..May disproportionately be improved in Leronlimab receiving patient’s.. MAKE THESE THE PRIMARY END POINTS..!!!

We may be interested in Post Covid Strokes..BUT .. if you cannot get to a Statistically Significant Level..Because there are NOT ENOUGH STROKES in a small population of Long Haulers..Make Strokes a Secondary End Point..Not a Primary One.. !!!

Rushing into a Long Hauler Trial ..To determine what symptoms we can treat.. MAKES NO SENSE..When we have these 281 patient’s..who can guide us..!!!

IMHO..