- **WP1: Non cost extension Liconsa**. Based on the timelines for the clinical trial. We need to ask EDCTP for a non cost extension. Delays in regulatory approval
- AK: We wont get everythinig clear before june 2026, therefore the non cost extension will be starting to discuss with Ana Duarte (project officer at EDCTP). For all to be clear, all info that pertains to WP3,4 and 5. All info that is needed should be ready by july august 2025. The main reason is to have wp2 finishing al the activities related to the visit on month eleven and everything related to closing the clinical trial. For how long? 6 or 12 months?
- JM: STOP already needed that and was extended to 5 (it was 4 before). We need to know that they can stretch the budget on site. EDCTP is quite flexible in providing the ok, I don't think they'll deny it, but the budget need to allow teams to survive until then.
- 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. 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.
- AK: That s somehow happening. The team from liconsa and your team are setting the list of activities and laying them in the calendar. Regarding this non-cost extension, your advice and suggestions are welcome.
- CV: Si todo va bien la preliminary opinion será el [[2025/01/30]]. In kenya still looking for a local agent. Submissions in latam and india after EMA.
- AB: We're in a good place for PQ. Its not on liconsas side to make the offer. WHO makes out a call for expresions of interest. They have never put out a call for a FDC. We're in the process of supporting WHO to draft that call for a FDC. In early 2025 allow them to Liconsa to react to that: we have a product that can go for your consideration. That would start the formal PQ process. Maybe 6 months, maybe a bit longer. If things go as planned,
