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3.2 KiB
3.2 KiB
- # #Tareas
- DONE REUNIÓN STOP2030/Steering Comittee/2024-10
SCHEDULED: <2024-10-03 Thu>
- ### A tratar
- Milestones and deliverables.
- EDCTP reporting
- Interim report
- FDC registration plans
- ### Notas
- Alan pide retrasar un mes el White Paper sobre sustainable supply and financing model
- Tenemos que mirar todos los due dates de nuestros deliverables y ofrecer fechas alternativas en caso de que haga falta retrasarlos
- En enero empezamos el financial oficial report. Enviaré un email y todo el mundo tiene que enviar a Liconsa (a Carla) para compilar todo el budget disponible.
- Interim report: cada partner tiene que enviar las cosas en noviembre o diciembre de 2024 para enviar en enero a EDCTP por parte de Liconsa. Hay que hacer un recuento narrativo del trabajo que se ha hecho al respecto.
- My proposal is
- Timelines and progress for the REALISE study
- Habla Jose Muñoz.
- Regulatory status:
- For SERU (IRB) we're waiting for the final aproval. expected by the end of september. Submission to PPB and Nacosti (la otra agencia)
- Ghana: final authorization from Ghana is expected very soon.
- Protocol amendment: Our hope is having everything ready before the end of the year.
- Pretrail qualification visits done.
- Se debería fabricar todo entre octubre y noviembre.
- Kenia: not before end of feb. 2025 Ghana: nov 2024.
- Data management plan: end of year. I'm working on it, a little bit slow because we were con el tema de PQ visit y nosequé. End of the year para tener el data management plan.
- Ale dice que es el clinical data management. El documento está written y ahora tenemos que actualice what is done. For the CRF.
- Steve:; the -80 ºC storage is being solved. All very positive.
- WP4. Proponemos 2 arm study comparing acceptability and feasibility of FDC versus ALB.
- Requirements: FDC aprobada. Readiness of country (de dónde viene la FDC). Recomendan hacerlo después de un exitoso REALISE y aprobación. Que esté listo para ERC el 30 de noviembre? pero queremos que esté la FDC registrada ANTES de enviarlo.
- En EMA que expect to get more queries from EMA en Oct. We have 1 month. If everything goes well we'll get the preliminiary opinion en Dec.
- A Ghana se mandó en June. Seems to be 6 month approval. FDA seems to be 6 months.
- In Kenya we're trying to find the best way to submit the dossier. We're exploring and trying to do it as fast as we can.
- Once we get EMA approval we might send to CL, CO, EC, PE and Brasil, and India.
- Vamos a pedirle al departamento de NTD de WHO que se lancen a pedir la inclusión en la lista de medicamentos esenciales. Moxidectin está en el mismo sitio.
- ASTMH: Coordinated by Stella and
- Mayor landmark yesterday. Painful process: We tried with a very high impact journal. ALIVE trial accepted for publication in Lancet Infectious Diseases. Good news.
- Request the manuscript.
- Ghana got a stop to prepare in ASTMH
- Status of moxidectin: 45 minute presentation. access and supply issues. Helpful to llisten to because they work a similar path.
- 70cts and 1dollar as the highest.
- ### Decisiones
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