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steveporsche

02/12/12 5:18 PM

#136924 RE: mcbio #136921

CLDX - FWIW Jefferies & Co does not even include CDX-011 in their revenue forecasts, so poor results in the breast 2b might not hurt the share price that much. Hopefully the placebo crossover component in the CDX-011 2b will not hurt or confound the results.

Jefferies: "After applying a 25% risk-adjusted discount to reflect clinical/regulatory risks, we estimate 2026 rindopepimut sales of $465 million ($621 million unadjusted) based on market share of 70% in the EGFRvIII overexpressing segment and 19% in the overall GBM market. We estimate rindopepimut pivotal Phase III ACT-IV data to be available H2 2016 with BLA filing 2017, FDA approval and launch late 2017/early 2018. Potential accelerated approval driving a shorter time-tomarket is upside to our estimates. We have not included ex-U.S. rindopepimut sales or sales in other cancer indications in our estimates. We do not include sales estimates for the rest of Celldex’s pipeline given the early-mid development stage with additional data needed to better delineate clinical profile and outlook for each drug candidate."