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Re: AMB67 post# 135910

Sunday, 02/14/2021 5:31:05 PM

Sunday, February 14, 2021 5:31:05 PM

Post# of 174801
Funny, I don't consider taking their latest input as their most accurate input as cherrie picking.

Yes, on Jan 19, 2021 they tweeted they had an early summer '21 for IDL submission. But 3 weeks later on Feb 11 they tweeted ""We remain focused on securing the Investigational Device Exemption (“IDE”) from the FDA and believe that this can be achieved on or around the end of the 2nd quarter of 2021."

I believe the later estimation is formed based on progress made since Jan 19 and as such I think it is reasonable to assume that it is accurate than the estimate made weeks prior.

End of 2nd quarter of 2021 could refer to second quarter of the calendar year or second quarter of their fiscal year. Happily, for RDGL they are one and the same. End of second quarter is Jun 30, 2021. Because they said end of 2nd quarter 2021 there is no confusion as to whether it is May or August.

The fact they are confident enough now to put out an 'on or around' end of second quarter estimate for IDE approval is great news and should be considered as such.

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