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8.1¢ nuheara limited

I reviewed the video and you are right, they need to get their...

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Catgut

4,226 Posts.

44

07/02/24

23:02

Post #: 72294237
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Originally posted by rigormortis: ↑

The webinar indicates they have not yet applied for FDA approval. She says they are still tweaking the device and do not expect approval until the second half of the year (assume calendar year). As it took some time to process approval for gen 3, I (not her) hope that means submission by at least mid year. She also implied launch will be before next CES.

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I reviewed the video and you are right, they need to get their in-house tests done and related documents filled out before the submission. Plus she says the estimate of time for approval assumes it has a 95% chance of being expedited by the FDA, so there is an additional risk there.

NUH Price at posting: 9.6¢ Sentiment: Hold Disclosure: Held
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