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Re: Investor2014 post# 443248

Tuesday, 12/19/2023 5:29:05 PM

Tuesday, December 19, 2023 5:29:05 PM

Post# of 464854
I read the EMA timetable as also giving CHMP plenty of time to process the request to be eligible, that the timeline does not depend only on the company's expeditiousness. In this instance, it seems to me CHMP acted very quickly. I'll have to ask Bard how long CHMP typically takes before making that decision. ;)

I meant that as a joke. But then I acted on it anyway. It said there's no definitive timeframe and it depends on various (enumerated) factors. But then it adds,

While there's no definite timeframe, several estimates exist:
...
Industry sources: Some sources suggest an average timeframe of 2-3 months for the CHMP to reach a decision on eligibility.


You've said you invest primarily in European biotech. Do you have a sense of whether the one-month turnaround was unusually quick? Clearly you don't think seven months is needed from the time the eligibility request is submitted before Anavex can submit its MAA, as you have "suggested Anavex might get their MAA submission in by end Q1 2024."

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