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iwfal

03/27/20 3:55 PM

#229942 RE: DewDiligence #229909

RVNC

TWSTRS is used to assess the severity of cervical Dystonia and the success of its treatment. The average of the change from baseline in TWSTRS-total score at Weeks 4 and 6 will be determined. TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes.

It is made up of the summation of 3 subscales: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).



Agree that two of the subscales are patient reported. But the severity one, that would ordinarily be the least noisy, is likely to be a lot noisier. It may turn on how overpowered they are?

Link below is to a list of the items on the severity subscore. It’s pretty precise (eg using 22 deg, not just 20 - implying it matters), so not clear how that would work remotely.

https://www.desitin.no/fileadmin/web_files_no/downloads/TWSTRS_severity_scale.doc

BTW - I expect that a lot of trials in biotech will be significantly compromised. It may be better to pause them then try to keep going and taint results. Or work with FDA to get permission to censor or ...?