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Re: DewDiligence post# 93110

Thursday, 03/25/2010 8:10:25 PM

Thursday, March 25, 2010 8:10:25 PM

Post# of 252455
I didn’t think NVLT would follow through with its HCV program, but Zebra’s Law has prevailed again:

http://finance.yahoo.com/news/Novelos-Therapeutics-Enrolls-bw-230803295.html?x=0&.v=1

The “phase-2” trial (quotation marks intentional) includes 36 patients in the second-line setting and is hardly what I would consider a serious effort (http://clinicaltrials.gov/ct2/show/NCT01058512 ):

There is no control arm, so it will be impossible to compare NOV-205 to the SoC.

• There are only 9 patients in each arm.

• Assignment to one of the four monotherapy arms is not randomized.

• Standard efficacy metrics such as RVR/EVR/SVR are not endpoints (and might not even be reported).

In short, this is effectively a phase-1b trial being disingenuously characterized as a phase-2 in order to hoodwink unsophisticated investors.


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