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Ann: Kazia's paxalisib awarded Orphan Drug Designation, page-19

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novogenbuyer

856 Posts.

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25/08/20

07:49

Post #: 46785035
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Originally posted by bmfjch: ↑

I think Kazia currently haven’t applied for FTD for DIPG and this is implied in the below comment from the announcement today. (That is not to say they wont apply in the future though).

“...This award of ODD concludes a program of regulatory optimisation that Kazia has initiated for paxalisib over the past six months...”

Also, it might be worth noting that there likely will be some added benefit from the FTD process for glioblastoma for other indications as the marketing application would contain some similar components.

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I don't think they have either. I think they would at the very least need very strong Phase 1b data in order to show some efficacy to apply for FTD and ensure they weren't wasting their time. I think FTD is usually granted based on Phase 2 results, though.

KZA Price at posting: $1.09 Sentiment: Buy Disclosure: Held
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