Ayala Pharmaceuticals Inc (ADXS)

[foggdogg]

When we get approval, we get exclusive marketing rights for 7 years. Coming soon


Advaxis Submits ADXS11-001 for Orphan Drug Designation

Orphan Drug Designation is intended to support the clinical development of drugs to treat diseases that affect less than 200,000 people in the United States. If approved, such a designation would grant Advaxis fast-track review process as well as market exclusivity for a period of seven years. In addition, Advaxis would be eligible for direct guidance from the FDA for the design of a clinical plan to further develop the drug. By statute, the FDA must review and respond to an Orphan Drug application within sixty (60) days.

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