https://seekingalpha.com/article/4284940-clinuvel-aces-sleeves-monte-carlo-valuation
"While the FDA approval seems to be a very likely event, given the fact that there are multiple years of data on safe and effective use from Europe and that the FDA extended the PDUFA deadline instead of sending a Refusal-to-File letter, a FDA rejection would in the short term definitely be a setback for the company's future prospects. However, with both VP and potentially XP, there are two attractive orphan disease markets that the company could turn to instead, giving it a stronger focus on Europe (for VP) and Asia (esp Japan, for XP)."
https://www.intelligentinvestor.com.au/shares/asx-cuv/clinuvel-pharmaceuticals-limited
Annual Report expected 18 October 2019.
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