Ann: FDA Decision for FebriDx, page-81

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LongTony

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25/10/23

21:45

Post #: 70539814
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Originally posted by LongTony: ↑

I think this is the report from the FDA around their review (approval) of the MeMed BV test. The development of the test was partly funded by the US government.

https://www.accessdata.fda.gov/cdrh_docs/reviews/K210254.pdf

At the top of page 4 of the report they outline the results you get from the "machine that goes 'bing!'" 15 minutes after the sample is taken - the text is pasted as an image below. Apparently, according to the review, the test is very reliable and repeatable. However, it's very equivocal when it comes to viral/bacterial/nothing diagnosis, in fact so equivocal to my mind that IMHO it is useless!

As you can see with the score ranges, the MeMed test really creates very little certainty around what to do. A physician or other health professional can run the test, everybody pockets their rebates and they can then prescribe antibiotics for any score from 35 to 100, or maybe even even between 10 to 100. Who knows? And it takes so long (ie 15 minutes, which is longer than a standard appointment) that they'll only do the test if they really have to.

It's a win-win-win! The physician can say they've been diligent, the physician gets extra money, MeMed gets money, and the physician can still prescribe just as many antibiotics as ever, so pharma still gets their money.

When I first had the opportunity to invest in this, I asked Sam if the "industry" in the US was ready for FebriDx and he said the feedback was yes. But looking at the approval for MeMed BV and the knock-back of FebriDx, I'd say it's clear that they're not ready for a line on a piece of paper that says "Don't prescribe $4B US a year in un-necessary antibiotics."

I'd say there's still a big push needed to get the FDA, with its impure architecture, to approve FebriDx, because FebriDx puts a clear line through $4B of Pharma revenue, and although the US says they want to stop, their are too many people riding on that gravy train.

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Reference to my own post sorry!

It contains a brief overview and my assessment of the direct competitor test (MeMed) that was used as the reasoning for rejecting FDA approval back in 2022.

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