Sounds like NSB do not currently have enough data that can justify a P1 trial in 88 patients which involves a spinal tap and risk of harm to the patient. I don't think this outcome is a significant negative for NSB, but simply that NSB may need to make some changes to their trial protocol and/or generate more data to justify the current trial design.
As the announcement mentions, the risk / reward skew is too far leaning towards greater risks for participants.
Ann: HREC decision to not approve Phase I Clinical Trial, page-63
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