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Ann: FDA Strategy and Regulatory Update, page-61

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Mayer29

75 Posts.

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02/09/20

08:46

Post #: 47008288
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Originally posted by BlueSky0301: ↑

Yes you probably right. But remember a decision could come any day between 61 Day to 90 day (By Day 90). Also when FDA is happy with the additional information they are after, in this case it seems they are, it takes a lot less time then usual. In my previous post I mentioned one ASX listed company had their approval in just 5 Weeks, yes 5 weeks. So FDA approval could come any day from now on...could take a while as well. GLTAH.

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What was the ASX company that had approval in 5 weeks for a 510(K)? Was that this year?

I would love to be proven wrong but I would think that approval will come in late November-December. Not downramping, just being realistic.

MEB Price at posting: 1.2¢ Sentiment: Buy Disclosure: Held
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