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Thanks for clarifying. My misreading of Chimerix as Chimeric,...

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Oupa

354 Posts.

51

27/04/23

11:07

Post #: 67476690
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Originally posted by Rinnekin: ↑

I am happy to be clearer with my speculation: The interim data from the PNOC study in DIPG will be for the combo therapy of paxalisib with ONC201.
Data permitting, both companies would need to approach regulatory bodies together and provide evidence on their individual compounds from mono studies but more so from the combo study.
Neither company can do this on their own due to the combo treatment nature of the PNOC study. Given the interim nature of the PNOC study data and the FDA‘s reversal of previous approvals for PI3K inhibitors a conditional approval requiring further data wouldn’t be out of the ordinary.
Especially as the PNOC study lacks a control arm. Though in my opinion a sufficient large difference in median overall survival in the study population vs historical controls should be enough in a disease area without approved innovation since the 1960s.

Does this address your question (somewhat)?

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Thanks for clarifying. My misreading of Chimerix as Chimeric, was causing my confusion.
Apologies for that.

KZA Price at posting: 18.5¢ Sentiment: Hold Disclosure: Held
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