- 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.
- 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.