“If FDA is going to approve a drug, my guess is they want to see that leronlimab alone provides benefit.”

I would disagree…there are lots of examples in medicine where multiple agents are needed. There are scores of regimens in oncology that involve multiple oncology drugs… they work together, not alone. A non-oncologic example would be a dual synergy antimicrobial approach involving gentamicin and a beta lactam antibiotic*. Take a random walk down the OTC’s in the drug store and note how many are compounded with multiple agents.

The “prime and pair” thesis is enough to put Leronlimab up for approval by the FDA IMHO.


*”The basis for the synergistic effect is that the beta-lactam antibiotic disrupts the bacterial cell wall, which then facilitates the intracellular uptake of gentamicin (an aminoglycoside). Alone, gentamicin has limited ability to penetrate the cell wall of certain bacteria, such as enterococci. The combined action results in a bactericidal effect that is greater than the sum of the individual drugs' activities (2+2=5 effect).”