From 74e70bf3b1fb045f2531c36e41acefc5c706504e Mon Sep 17 00:00:00 2001 From: borja Date: Thu, 5 Dec 2024 15:24:41 +0100 Subject: [PATCH] Auto saved by Logseq --- journals/2024_12_05.md | 1 + 1 file changed, 1 insertion(+) diff --git a/journals/2024_12_05.md b/journals/2024_12_05.md index 658ac6f7..72c41a89 100644 --- a/journals/2024_12_05.md +++ b/journals/2024_12_05.md @@ -46,5 +46,6 @@ - CV: I'll let you know whenever they tell me anything about this non-cost extension. She confirmed we need to do an ammendment. - CV: Si todo va bien la preliminary opinion será el [[2025/01/30]]. In kenya still looking for a local agent. Submissions in latam and india after EMA. - AB: We're in a good place for PQ. Its not on liconsas side to make the offer. WHO makes out a call for expresions of interest. They have never put out a call for a FDC. We're in the process of supporting WHO to draft that call for a FDC. In early 2025 allow them to Liconsa to react to that: we have a product that can go for your consideration. That would start the formal PQ process. Maybe 6 months, maybe a bit longer. If things go as planned. We anticipate those pieces in early 2025 to follow closely on the tails of the EMA decission. That would fall nicely into place in 2025. They may say that they want to see or weight the extra effectiveness and expanded safety data. + - AB: the call is only for STH. its for an indication and a specific medicine. The level of precision is very narrowly defined. - ### Decisiones - \ No newline at end of file