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BTH

02/12/12 6:09 PM

#136925 RE: steveporsche #136924

I was under the impression that CDX-011 was THE reason to be involved here. Am I mistaken?

mcbio

02/12/12 7:48 PM

#136937 RE: steveporsche #136924

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."

If we are talking biggest near-term impact on share price, 011 is the key, not 110 IMHO. There will be near-term important data on 011 while 110 Phase 3 data is a ways away. Also, 011 is addressing a much larger potential market than 110 and is addressing every bit as much of an unmet medical need patient population as 110. It might even have a shot to make it to market earlier, provided data is strong in this unmet medical need patient population. So, I don't understand why someone would key in on 110 when trying to come up with a fair valuation for CLDX and ignore 011. Doesn't make much sense to me.