Why IMU is a multi multi bagger, page-29494

I hear you on SOC and yes, that's the traditional way to get to market ... demonstrate that your product has a cost/efficacy/tolerance advantage over the current best available

BUT ...

... aren't there 'ethical' short-cuts available if a product demonstrates safety (that box already ticked) and represents a 'step-change' in effectiveness? In that case it's not acceptable to construct or continue with a trial that leaves half the participants on the lower step.

I stand to be corrected but if, say, early trials of an IMU therapy show 80 or 90% effectiveness in patients who have already received the best SOC available, it would be pretty tough to even recruit people with earlier-stage disease into a traditional 'against best available SOC' trial.

If we truly have a novel and magic bullet and can demonstrate it with sufficient numbers of 'nothing-to-lose' patients then approval to market will appear quick-smart without the need to 'wait and see'.

Didn't we just see that happen with COVID treatments? The other side of that coin ... the disease in that case was 'novel' too ... nobody hung around organising traditional trials that left numbers of patients on the best SOC available, because the best available simply didn't work.

Before that? AIDS. Similar story ... SOC was ineffective to the point of being a death sentence for many.

There's no doubt that clinical trials are the highway that we need to follow but ultimately they are an artificial construct capable of being altered to fit reality so if we are lucky to be invested in this stock and it turns out to be a game-changer maybe we should not think in terms of 'z must follow y must follow x' ... the highway starts to look more like a runway, right?