correct. for FDA approval a device or drug needs a study done in...

correct. for FDA approval a device or drug needs a study done in the US. for phase II that can be around $5m, phase I cheaper. Phase 3 5-8m depending on size etc.

But unless they are planning an imminent trial and have the research contracts already done, the study protocols finalized and ethics submissions ready to be submitted, Im puzzled why they felt the need to offer a 50% discount while at the all time lows.

Seems incompetent to me; unless there was pressure to get the insto's reset cheaply to average down which is more likely. Still shafts holders on their current holdings even tho there will be a rights issue in due course.