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Ann: Invex receives IND approval, page-33

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24/08/22

20:03

Post #: 63303091
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Originally posted by SSilverstein ↑

Just sent this off to Tom, feel free to comment if you think you can help.

Hi Tom, just a few questions from shareholders when you have the time.

Has the EMA stipulated what percentage reduction in ICP is required for regulatory approval and is that public information? (Phase II had 10%, 16.5% and 18%-20% for the results so just wondering the ballpark there)

Is it a binary percentage term or is there some leniency built in to the approval?

Is the percentage reduction in ICP required for approval determined by previous clinical trials, or if not, what is it determined by?

If the primary endpoint is met and none of the secondary endpoints are met will the drug be approved? (Are the secondary endpoints there for drug pricing and patient benefit more so than approval?)

If the EMA approves Presendin, will the MHRA and TGA definitely approve it as well, or is there some discretion there?

What steps would need to be taken to get regulatory approval in jurisdictions other than the UK, EU and AUS (China, India, Africa) and is that something that Invex has considered, if so, why has Invex elected to not pursue approval in those jurisdictions?

Expand

Way over my head
But appreciate your diligence
I would simply ask if the drug works what will the share price be ?

IXC Price at posting: 64.8¢ Sentiment: None Disclosure: Held
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