- 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 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.
- 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.
- SD: well be sampling people in may-june? Probably perfectly good news. After a productive site visit and finalize what we need in terms of samples. we have everything ready. My samples team hasn't had a lot of luck. But contact
- SD: well be sampling people in may-june? Probably perfectly good news. After a productive site visit and finalize what we need in terms of samples. we have everything ready. My samples team hasn't had a lot of luck. But contact in ghana and kenya to receive consumables for sample collection. (ellos ya los tienen). We need people that makes sure they arrive safe. Almudena can get the info for them.
- AB: The customs clearence is all clear?
- ### 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