VRS37
You are conflating two different issues. Read the Business Update. An RCT may be required to access public funding. EG:- A NICE approval for instance may well require an RCT.
But they didn’t need an RCT for Ce Mark approval, nor is one required for the private payer market. Regulatory approvals may also not require a full blown RCT. TGA approval which recognises CE Mark does not require an RCT.
Theraspheres and FDA approval, page-5
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