Celldex Therapeutics Inc (CLDX)

[kris_kade]

Here is the link:

http://boardvote.com/symbol/CLDX/communique/205900


CDX-011 Developments



In December 2012, we had our end of Phase 2b meeting with the United States Federal Drug Administration, or FDA, for our CDX-011 program, which we have characterized as positive. Based on this meeting, we intend to initiate a CDX-011 study suitable for accelerated approval in the second half of 2013. We are currently finalizing the clinical trial design and will update investors on our plans for the accelerated approval trial on our year-end 2012 call in early March 2013. Also in December 2012, we announced final results, as shown below, from the EMERGE study which suggested that CDX-011 induces significant response rates compared to currently available therapies in patient subsets with advanced, refractory breast cancers with high glycoprotein NMB, referred to as GPNMB, expression (expression in greater than 25% of tumor cells) and in patients with triple negative breast cancer. The overall survival and progression free survival of patients treated with CDX-011 was also observed to be greatest in patients with triple