Biotech Values

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Avastin hasn't got approval in Ovarian cancer in US because OS data aren't there. EMA is always willing to approve based on PFS. But they have different system, member states decide reimbursement on their own. Approval with PFS doesn't mean reimbursement. They need to support additional data for cost benefit analysis to each member state to get reimbursement.

Look at CRME's Vernakalant, FDA declined to prove it, EMA did, but it doesn't get much if any revenue there despite approval. It is a lot harder to get reimbursement than approval in EU.