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Anshu2

12/02/22 12:49 AM

#387436 RE: Doc328 #387431

Thanks, Doc, for your points.

One more: What do you think if the discrepancy between baseline numbers on slide #16 vs 21? (For Cog scores).

The footnote of slide 16 says : “5 patients not randomized”. Could the discrepancy be due to this? Why would 5 patients not be randomized?
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raja48185

12/02/22 12:53 AM

#387438 RE: Doc328 #387431

According to slide 26, 161 of 170 ITT (or 168 mITT) patients on placebo patients made it to the maintenance phase after titration --- so 7/168= 4% dropped out during initial titration . However only 301 of 338 ITT (or 335 mITT) made it to the maintenance phase after titration --- so 37/335 = 11% dropped out during titration

I know it is mid night/early morning. But check numbers again

Is it 37/335? Vs 7/168
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Hoskuld

12/02/22 12:53 AM

#387439 RE: Doc328 #387431

The FUDsters are showing up in force. You guys bet wrong and you are getting smoked. Be good sports and take your L and go home.
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12x

12/02/22 12:59 AM

#387443 RE: Doc328 #387431

Are you suggesting both co-primary endpoints failed?

Also that would be a treatment mean difference of -1.34 not -1.85 (if true, this would not be p=0.033 but about p=0.15)

Either Missling was sloppy or wrong. Pick one. He'll probably blame it on the third party again.

The slides and/or PR also do not report the co-primary endpoint (ADCS-ADL) numbers just a +3.5 point responder analysis which was not the endpoint.

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frrol

12/02/22 5:57 AM

#387510 RE: Doc328 #387431

The dizziness issue has been evident since 2015, the AD phase 2A. This is the first time the company pointed out it can be additionally mitigated with bedtime administration of the drug.

On the discrepancies, I suspect we'll be getting explanations from the company quickly, maybe even a new results deck. With a one-day turnaround, a couple mistakes will happen (Though simple double-checking can catch them.)
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peeved

12/02/22 6:10 AM

#387517 RE: Doc328 #387431

How can you tell the statistical significance would be p=0.15 when we dont know exact n?

Also why are baseline scores from slide 16 sooo different from 21? Even in placebo arm

For the adcs-adl endpoint: how can there be a significant. 3.5 difference without the actual numbers or score being different?

Thanks again