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17:20
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Originally posted by zeno9:
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Hi MichaelDe Novo applications can take up to 12 months, which means in a worst case scenario, approval for Coris may not come about until the end of April 2025 . As if to reinforce the plausibility of that scenario, Michael Kavanagh went on to say that the company was not expecting any revenue from Coris in FY25 .FDA's past experience with priority review programs indicates that innovative products may raise additional scientific and regulatory issues that warrant more in depth review during FDA's review of the marketing submission. Therefore, the timeframe for review of the marketing submission may take longer for devices in STEP than for other less novel devices ."
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I thought the JP Morgan analyst was simply trying to ascertain how much of a delay the questions from FDA, the subsequent responses from Nanosonics, and then the consideration of those responses by FDA might add to the eventual approval process for Coris.
(20min delay)