Replies to post #123873 on Biotech Values

[projectchris]

Neop longs claim it is a better product than the SOC.




from 2010 annual report http://neoprobe.com/annualreports/2010AnnualReport.pdf

"In connection with the end-of-Phase 3 meeting held in March 2010 with FDA for NEO3-05, we also
engaged FDA about amending the design of our third Lymphoseek Phase 3 clinical trial (NEO3-06) in
order to specifically support claims aimed at sentinel node detection in subjects diagnosed with head and
neck squamous cell carcinoma. Claims for sentinel lymph node mapping are intended to have a very
specific focus distinct from claims for more generalized lymphatic mapping and anatomic delineation of
lymphatic tissue. We began enrollment in the trial at clinical sites in the United States 2009 and are
actively working to expand the trial, including the possible extension to clinical trial sites in Europe. The
sample size calculations performed for NEO3-06 have modeled a total number of subjects of
approximately 300 subjects for full completion of the study with a planned interim analysis to assess
performance at approximately the halfway point. The potential interim analysis of the clinical data from
the NEO3-06 study may occur by the end of 2011."




The NEO3-06 trial comparing lymphoseek to radical ALND in Head & Neck cancers will be a very interesting study imho. I think enrollment for Head & Neck is currently at 190 patients, so I suspect the interim analysis is near.