This company did it the right way by getting EU approval first...

This company did it the right way by getting EU approval first and then seeking investors outside the market.  A fraction of share outstanding compared to POH. Now seeking FDA approval. Just heard the CEO talking about it. He said companies overstate the importance of efficacy to regulator (EU & FDA). The regulators are more concerned with long term safety. I know, If only and what ifs ....Pointless now other than to educate for future investments.

Clinuvel Pharmaceuticals Limited (CUV) is a biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. CUV's lead compound is SCENESSE (afamelanotide), a drug targeting erythropoietic protoporphyria (EPP).