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Ann: Appendix 4E and Annual Report, page-71

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edb11

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17/09/21

16:19

Post #: 56156827
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Originally posted by SSilverstein: ↑

As per the February 2021 Investor presentation this is the timeline we are working with. ^^^

However, as per the August Annual report, the board mentions that their preferred course of action is still attempting to "harmonise the Phase III design to meet the requirements of both the EMA and US FDA for registration of etc". Which probably means they're trying to figure out a way to either convince the FDA to allow ICP or headache days to be the primary endpoint or run a phase III trial with a primary endpoint in ICP or headache for EU, and a secondary endpoint in PMD for FDA which would then mean they only need one more trial for the FDA before regulatory approval. In any case, I think the main reason for the delays is the curveball the FDA threw when they asked for vision as a primary endpoint, and then PMD out of all things.

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Thanks - appreciated.

So in your view, are you expecting to have clarity on either the harmonised trial or going it alone in EU by the end of the year?

IXC Price at posting: 68.5¢ Sentiment: Hold Disclosure: Held
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