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Re: DewDiligence post# 516

Sunday, 02/25/2007 8:18:04 PM

Sunday, February 25, 2007 8:18:04 PM

Post# of 3757
>>> Isn’t that’s a strong assumption for the follow-up (non-treatment) period of a phase-2 clinical trial? As these patients are not permitted to switch to another therapy during the six-month follow-up period, what information of practical use would be gained by conducting a blood test every month? <<<

I really don't know how extensively patients are tested during or after the dosing period. It's just that PJ seems to have some information that probably should be blinded to them and everyone else. That being the case , and given the statements made in the report , I speculated on a data collection protocol that could hypothetically provide that sort of data. We know that VRTX looks at 3-month SVR data. Both companies may collect more data than is revealed publicly , as a means to try to understand what's going on with treatment failures , or in the interest of patient safety ( to detect hepatic flares , for example ).

The other possibility , though less likely , is that patients get tested off-site.

My main point is that if we assume PJ can get SVR data then we have to assume they can get other data as well , and to the extent that any off-treatment data is collected , it could provide a measure of SVR in advance of the final SVR time point.

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