Okay, might as well ask some questions for $FREQ longs:
Link to Ph1b paper: journals.lww.com/otology-neurot…
Link to patent:
patentimages.storage.googleapis.com/1f/4b/8f/186fc…
Link to Ph1b paper: journals.lww.com/otology-neurot…
Link to patent:
patentimages.storage.googleapis.com/1f/4b/8f/186fc…
$FREQ 1. In the paper, they say at Day 90, 4/15 FX-322 treated ears had a 10 dB improvement at 8000 Hz, while no placebo showed this level of improvement.
That sounds great! But that doesn't mean placebo patients didn't show any improvement
That sounds great! But that doesn't mean placebo patients didn't show any improvement
$FREQ 2. In fact, a placebo patient did have a 5 dB improvement (which is important later) at 8000 Hz
More questionable is that several placebo patients had 10 dB improvements at 8000 Hz on Days 15, 30, and 60. They just happened not to on Day 90
More questionable is that several placebo patients had 10 dB improvements at 8000 Hz on Days 15, 30, and 60. They just happened not to on Day 90
$FREQ 3. Now this graph that caused a hubbub:
A "responder" is defined as a patient who had a 5 dB improvement AND a +10% improvement in word recognition (WR) OR word in noise (WIN)
Clearly there was some placebo benefit...just not on Day 90.
A "responder" is defined as a patient who had a 5 dB improvement AND a +10% improvement in word recognition (WR) OR word in noise (WIN)
Clearly there was some placebo benefit...just not on Day 90.
$FREQ 4. Now looking at the WR vs WIN graphs, patients 918 and 938 have an improvement in one, but declined in the other - should these not be more correlated?
$FREQ 5. Furthermore, since the improvement is a % change from baseline, it's important to look at the baseline. It's pretty clear that these FX-322 responders had such a low baseline that% changes are more drastic
$FREQ 6. Now FREQ has a lot of endpoints to play with, so I'm sure they'll find something.
They are also measuring up to 16,000 Hz, but isn't that towards the outer part, and aren't frequencies between 250-8000 Hz the most important for hearing? Drug delivery issue?
They are also measuring up to 16,000 Hz, but isn't that towards the outer part, and aren't frequencies between 250-8000 Hz the most important for hearing? Drug delivery issue?
$FREQ 7. As for expectations, FREQ KoLs said a 10% improvement in WR is clinically meaningful - but only if they were at a reasonable baseline.
And as for tinnitus, they company said "we don't know what the effect is on tinnitus"
And as for tinnitus, they company said "we don't know what the effect is on tinnitus"
Shoutout to @NoseRubInvest who did 90% of this work while I sat around testing to see if I could hear really high frequencies (I could not)
@NoseRubInvest $FREQ Oh, and as @drug_smolecules points out, why are these two Word Recognition graphs different - one from the paper, and one in their investor presentation
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