Non-clinical data
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- Page 2: Data presentation for experience claims appear to be misleading and ambiguous. Please differentiate this section as part of a PSP. We also question the experience claims overall. Please provide attestation letter from the sponsor's medical/regulatory department as adequate support (s.4.1, s.4.3).
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Agree. Need attestation and need more detail on what these claims refer to -- agree that they are part of PSP, not necessarily specific to ArradiCAN