- **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
- **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
- **WP1: Regulatory aspects.**
- **WP1: Regulatory aspects.**
- **WP5: PQ at WHO.**
- **WP5: PQ at WHO**
- **WP1. Interim report**
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- ### Notas
- ### Notas
- 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?
- 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.
- 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.
@ -48,6 +50,7 @@
- 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. We anticipate those pieces in early 2025 to follow closely on the tails of the EMA decission. That would fall nicely into place in 2025. They may say that they want to see or weight the extra effectiveness and expanded safety data.
- 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. We anticipate those pieces in early 2025 to follow closely on the tails of the EMA decission. That would fall nicely into place in 2025. They may say that they want to see or weight the extra effectiveness and expanded safety data.
- AB: the call is only for STH. its for an indication and a specific medicine. The level of precision is very narrowly defined.
- AB: the call is only for STH. its for an indication and a specific medicine. The level of precision is very narrowly defined.
- AK: They may request additional data. We have started to revise a new version of the systematic review of high dose ivm during the pandemic. Registered in PROSPERO. When any news brought here. That would be useful
- AK: They may request additional data. We have started to revise a new version of the systematic review of high dose ivm during the pandemic. Registered in PROSPERO. When any news brought here. That would be useful
- AB: We've missed the EoI deadline. I didn't know until recently that ALB and IVM arae in the EML, and ALB does specific mention of combination with IVM.
- AB: We've missed the EoI deadline. I didn't know until recently that ALB and IVM arae in the EML, and ALB does specific mention of combination with IVM. It makes it a lot easier than other medicines that have to make from scratch the case that they should be added. We're quite a few steps along the way.
borja
1 month ago