The CRL goes on to suggest that Lykos conduct a new clinical trial in order to address these issues, which it says should focus on:
- Demonstrating durability of effect
- Minimising potential for bias
- Adequately characterising the safety of MDMA
The agency provides more specific guidance for each of those broad areas of focus. It also recommended that Lykos “consider an independent third-party data audit of all study records and reports”, noting that FDA would still consider the existing data in the event of a future resubmission.
Once again, you can retrieve a PDF copy of the letter here.
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