Tim Boreham is one of Australia’s best-known small cap analysts and business journalists. share While proclaiming the US Food and Drug Administration’s approval of Clinuvel’s rare skin disorders drug Scenesse as a “momentous occasion for an Australian biotech company”, CEO Dr Philippe Wolgen avoids any hubris. “I’m very careful about using the word ‘success’ because the minute you proclaim success, the next day the house falls down,” he says. Dr Wolgen’s reticence is understandable, given Clinuvel’s (ASX:CUV) quest for the FDA’s stamp of approval as a ‘serious’ drug took more than 14 years. But he’s happy to highlight that not only has Clinuvel become one of the few Australian biotechs to obtain fully-fledged FDA approval, it did so while beating the key financial metrics outlined in a 2006 business plan. At the time, management decreed the drug needed to be developed for under $200 million, compared with the typical […]