Clinuvel Pharmaceuticals (CLVLY)

[ghmm]

PW = CEO Philippe Wolgen

Yes only approved in Europe not US. Concern is they apply the "uniform pricing" policy should they gain US approval. There are no trials ongoing in the US and according to the company FDA has said they are willing to accept the filing with current data. They still have not completed the NDA yet so we are still potential a ways off but they should be talking to payers now (actually some companies have preliminary discussions to get a sense much earlier) to get a feel for pricing/reimbursement.