Currently, all programs are fully owned by Celldex. Consequently, there is a need for additional therapies. All patients will continue to be assessed for response through week 12. &# These patients all experienced complete responses. &# CDX-527 CDX-527 is the first candidate from Celldex's bispecific antibody platform. We also rely on CMOs for labeling and storage for studies outside the US. All products are then filled at CMOs. Clinical trials are generally conducted in three sequential phases. As a result, we do not know whether they are safe or effective for humans. Any such action could materially harm us. The FDA has agreed to specified performance goals in the review of NDAs and BLAs. Our website is located at http://www.celldex.com. 8203; • Risks related to managing our growth. &# We had an accumulated deficit of $1.1 billion as of December 31, 2020. We cannot be certain that we will achieve or sustain profitability in the future. We disagree with their objection and believe their objection to be without merit. Our drug candidates are subject to extensive regulatory scrutiny. Phase 2 testing generally lasts between 6 and 36 months. We face intense competition in our development activities. We have limited experience in commercial manufacturing. We may not realize the anticipated benefits of our acquisition of Kolltan. We also face the risk that others will infringe, avoid or circumvent our patents.
