$PULM Pulmazole, an iSPERSE enabled inhalable dry powder version of the leading anti-fungal Itraconazole - yielding safety and efficacy improvements over oral dosage (PUR1900): ✔️ FDA Orphan Designation Status ✔️ FDA QIDP Designated Status ✔️ FDA-Fast Tracked ✔️ Successful FDA Type-C review meeting defining new end-points ❓ Cipla back on board with Pulmazole as one of their largest Specialties initiative per their annual report? ❓ LPAD pathway potential? ❓ Broadly applicable to other indications which Itraconazole is being prescribed, such as cancer? FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway), which encourages the development of safe and effective drug products that address unmet needs of patients with serious bacterial and fungal infections. Specifically, an antibacterial or antifungal drug approved under the LPAD pathway is used to treat a serious or life-threatening infection in a limited population of patients with unmet needs.
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