- I got in touch with EDCTP authorities to highlight that PZQ and moxi and fdc are all edctp invesments. They are very happy about it.
- Maurice: what i gather is present the clinical findings and highlight what the next steps are. Im not in the access program. I just know generalically. They're trying to get aproval in Kenya. I cannot give many specifics but yes about the pivotal trials. The panel can take it from there.
- Stella: Those iinvolved in the access will be in the audience. Look at the path from inception to regulatory and next steps.
- Has the pzq been adopted in WHO recomendations. It was adopted in March of 2024. That is a big step. You're leading this. FDC is not there yet. Highlighjting that all the activities to include it in recomendaitons has already been acomplisehd. Its not done by us but by Merck. EMA for scientific opinion and the regulatory component that follows trough. Now that paves the way to countries to review and accept. Before that idenfi
- Has the pzq been adopted in WHO recomendations. It was adopted in March of 2024. That is a big step. You're leading this. FDC is not there yet. Highlighjting that all the activities to include it in recomendaitons has already been acomplisehd. Its not done by us but by Merck. EMA for scientific opinion and the regulatory component that follows trough. Now that paves the way to countries to review and accept. Before that idenfified the platforms to distirbute.
- MEntioning that these were necesary steps beyond clinical trials.
borja
2 months ago