- 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.
@ -54,7 +55,8 @@
- 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.
- 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.
- CV: Interim report, add it to the word document
- CV: Interim report, add it to the word document
- AL: Protocol 2.0 we received full approval from ERC and FDA. Kenya we have IRB, waiting for PPB. We have made some ammendments to the protocol. They have to be submitted to the countries. 3.0 pending submission. 4.0 it changes one of the inclusion criteria. Se sube a 110cm para que sean 15kg. Setup and preparation at sponsor and site levels is continuing. Liconsa will work on the export permit. The product has been manufactured and that allows the import permit in Ghana and wait for PPB for import in Kenya.
- AL: Protocol 2.0 we received full approval from ERC and FDA. Kenya we have IRB, waiting for PPB. We have made some ammendments to the protocol. They have to be submitted to the countries. 3.0 pending submission. 4.0 it changes one of the inclusion criteria. Se sube a 110cm para que sean 15kg. Setup and preparation at sponsor and site levels is continuing. Liconsa will work on the export permit. The product has been manufactured and that allows the import permit in Ghana and wait for PPB for import in Kenya.
- AK: Fernando aguirre said in an ideal situation we start on march. best case scenario. but the bulk of the recruitment seems to be happening in May. this is to justify we'll be in june 2026
- AK: Fernando aguirre said in an ideal situation we start on march. best case scenario. but the bulk of the recruitment seems to be happening in May. this is to justify we'll be in june 2026 will still have followup visits and then the db and queries and layers of review and clearing the data. Both countries seem to be aligning to a similar timeline. There are several items, but May june next year will be the most critical months for the trial.
-
- ### Decisiones
- ### Decisiones
- TODO Añadir el interim report al documento de Word STOP2030
- TODO Añadir el interim report al documento de Word STOP2030
borja
1 month ago