CLVS - What Does Breakthrough Therapy Designation Really Mean For My Company?
Author's note: This article was presented early to subscribers of the Total Pharma Tracker, and they also got further insight into how best to use these tools in making investment decisions.
The world of biotech investing revolves first and foremost around the regulatory agencies like the Food and Drug Administration (FDA) and European Medicines Agency ((EMA)). In particular, the FDA is arguably the single most important arbiter for what gets to pass, particularly in the world of cancer.
Oftentimes, they set the tone for what is acceptable practice in cancer medicine by being the