Selecting ROW partner(s) will be impacted by:
1. The approval by FDA. Prospective distributors will need to have discussions with ROW territory regulators, and receive advice from them regarding application requirements (eg whether further trials will be required). This will be impacted by the FDA approval.
2. Launch of DAYBUE by Acadia, especially the pre-launch resources they engaged, sets a benchmark for ROW candidates. It will need to be factored into their business case.
3. Acadia pricing of USD375k ave/patient price) will require prospective distributors to revise their financial cases, which would need internal approvals.
4. Revised offers by candidates will require due diligence by NEU to ensure that the candidate has the resources (both existing and planned) and understanding of regulatory requirements in the Territory to ensure success.
This is by no means a short process. Setting targets like EOFY or prior to the AGM just have no relevance, especially when candidates are required to await advice from Territory regulators. Any amount of discussion or pushing on HC is not going to make any difference.
I would be surprised if a decision to appoint a distributor(s) was made before the end of 2023.
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