Wait till the quarterly. ;) Have you joined that other site yet?...

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christophe

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10/01/19

18:23

Post #: 37084085
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Originally posted by tnicholl ↑

Originally posted by BkrDzn
FDA wouldn't be close so doubt there is any FOMO there. If they have sent an application in without informing the market, the FDA states the typical 501(k) takes around 90 days from the FDA confirming receipt of the application. I note many reviews take longer for various reasons and real word averages are closer to 150 days. Assuming IME has told us nothing, the earliest they've practically done it would be week 1 Dec, give a week to confirm then 90 days from there (best endeavours) So best case its a late March approval if nothing goes wrong and they are telling us nothing. Under the MDDS process for software it could be quicker but best I have found so far is that if its more basic software, it just is subject to less enerous compliance obligations. I note PME, VHT have 501(k) so doubt IME can do different. This is all before you factor in the government shutdown with the FDA running on C&M essentially.
Hi Bkr, thanks for your post. Great information. I am not expecting FDA anytime too soon (IE not within the next month at least). Just simply stating that people are typically more unlikely to buy when price is outside (above) the boiling band when in most cases it will cool off as it did today, unless there was some kind of FOMO reason (definitely not at the moment).

Nonetheless you have provided some great information that I wasn't aware of in terms of process and timing etc, thank you!

Cheers,

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Wait till the quarterly.

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If not hurry up! Lol

IME Price at posting: 3.3¢ Sentiment: Buy Disclosure: Held
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Wait till the quarterly. ;) Have you joined that other site yet?...

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