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Friday, 08/24/2018 12:47:30 PM

Friday, August 24, 2018 12:47:30 PM

Post# of 108192
FDA Allowance of IND Application for ADXS-HOT Drug Candidate for Non-Small Cell Lung Cancer.

Would not the IND application specify what checkpoint inhibitor from what company they would be using and the company that they using would need approve that use of their drug. The FDA would not approve the IND if it was vague checkpoint inhibitor so the company supplying the drug must agreed and some kind of deal must be completed.

The Company plans to initiate a Phase 1/2 clinical trial that will seek to establish the safety, tolerability and effectiveness of ADXS-503 administered alone and in "combination with a checkpoint inhibitor" in approximately 50 patients with metastatic NSCLC in different lines of therapy, at up to 20 centers across the U.S.
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