Ann: Final Patients dosed in SPONTAN pivotal study, page-92

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Tym1ng

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28/05/24

15:57

Post #: 74047674
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Originally posted by cdoyle: ↑

if it does demonstrate bioequivalence, this result could see us applying for and receiving approval to sell Spontan in Australia under early access scheme. So while the market is smaller in Australia, the company could be making revenue in 2025 potentially.

The big fish is going to be seeing what the FDA says in pre-submission meetings. But, a noteworthy risk is that if the FDA come back and say they weren't happy with the trial design, or the endpoints and a dose-escalation or P2a or P3 is required its going to make this pretty drawn out and would make it turn into years before hitting the US shelves.

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I think the CEO mentioned the company is aiming to generate revenue from product sale in AU in second half of 2024. Also, the trial seems to addressing FDA requirements.

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Ann: Final Patients dosed in SPONTAN pivotal study, page-92

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Ann: Final Patients dosed in SPONTAN pivotal study, page-92

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