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Ann: Update on US FDA De Novo Classification Request, page-315

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #

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Thegun96

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27/07/20

19:49

Post #: 46104380
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Originally posted by ScrimpyCat ↑

That is one possible outcome, though if we do need to conduct a third trial it probably won't be soon. A lot of things are delayed at the moment and getting another trial going might prove to be more difficult than previously. Look at how the economic evaluations have been postponed.

As far as whether we'd need to have another CR if we go ahead with a 3rd trial, possibly, but we do have enough to go ahead with it without another raise. It'll just come down to what they think those current funds are best put towards.

Regardless if a trial is needed, I'd like to see them leave it be for now and just focus efforts on commercialising in the current target markets.

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Just concentrate on the rest of the world
Forget USA
This will go North of $1

RAP Price at posting: 13.5¢ Sentiment: Hold Disclosure: Held
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0 Great analysis

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