- AK: How many shipments do you see? once all the samples are collected?
- SD: 2 per country. one after the one month collection. and the second one by the middle of 2026.
- AB: Relative to the project. It will be helpful to visualize it. Acknowledge that a no cost extension has a cost. We're mantaining the infra of the project for another year. Adjust budgets and levels of effort now for a potential extension. It is not as easy. WP5 will rely on data coming from the tail end of the studies. Aside from the budget implications, we're intereted in being transparent and reliable on what we say. Changes can make us risk us loosing credibility.
- AK: No cost is for EDCTP, not for anybody else. The first thought is how to justify this request. Based on the latest input from EMA regarding their judgment. I have no issues regarding the requeest to EDCTP. To keep the trust in us is that there are good reasons to request this. I take your point that the effectiveness component is relevant for WP5. but as far as que have all the safety data, the main goal around this we can move forward.
- AK: No cost is for EDCTP, not for anybody else. The first thought is how to justify this request. Based on the latest input from EMA regarding their judgment. I have no issues regarding the requeest to EDCTP. To keep the trust in us is that there are good reasons to request this. I take your point that the effectiveness component is relevant for WP5. but as far as que have all the safety data, the main goal around this we can move forward. Confirmirng whether we do it or not, its just a matter of confirming 6 or 12 and SD made a good point for the 12 months.
- JM: WP5 should do the argument with the prelimnary data.
borja
1 month ago