Avid Bioservices Inc (CDMO)

[vinmantoo]

Vin, mechanism of action matters not

True, in trials results matter but you should sure as hell have some idea of mechanism when you design trials, especially in combination trials.

I did notice you failed to acknowledge you were wrong when you said that 20% of HER positive tumors meant that only 20% of breast tumors express HER. As I pointed out, and the MAYO clinic site confirmed, HER positive tumors refers to tumors which HER2 is OVER-expressed based on histochemical assays, or FISH assays. Got it?

when you compare trial arms. You're trying to beat SOC. You don't measure MOA as an outcome. You measure OS or PFS in the control arm (e.g. chemo + adjunctive hormonal therapy, which is standard of care) versus the experimental arm (chemo + adjunctive hormonal therapy + downstream 1.0 anti-XYZers).

You can't isolate the effect of adjunctive hormonal therapy because it's in both trial arms.

Got it?

What are you talking about? These are the options. If the SOC is tamoxifen alone or Herceptin alone, then the trial arms could be tamoxifen alone or Herceptin alone vs IO + tamoxifen or IO + Herceptin. If the IO is the standard of care, your trial can also have two arms, one is the SOC, IO alone vs the combo of IO + your antigen specific antibody, hormone blocker, or antibody drug conjugate.

If both of your individual drugs are approved for that indication, then you have the option of a three arm trial, one arm of each single agent alone, with the 3rd arm being the combination arm. Got it?