The FDA Grants QIDP Status To Pulmatrix Inc (NASDAQ:PULM)

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Pulmatrix Inc

The FDA granted Pulmatrix Inc (NASDAQ:PULM) preclinical stage candidate ‘PUR1900’ a Qualified Infectious Disease Product targeting treatment of fungal respiratory toxicity in cystic fibrosis patients. This new status enables for accelerated assessment of the marketing application. Also, the company will have an additional 5 years of market exclusivity for the drug, if approved. PUR1900 incorporates dry powder iSPERSE technology, using which it intends to overcome the different limitations of old metered dose and lactose blend inhaler technologies.

The buzz

Pulmatrix reported 3Q2016 financials back in November, wherein the CEO Robert Clarke reported that they posted strong progress in the quarter. The management is extremely delighted with the awareness building around iSPERSETM. They are in the process of using this technology and will leverage this platform to get a differentiated product pipeline for treatment of grave pulmonary problems. Last quarter, together with Mylan, they posted favorable pharmacokinetic report for PUR0200 in COPD which supports accelerated progress in the EU through the Pharmacokinetic Bioequivalence Regulatory Control.

FDA approved Orphan Drug status for PUR1900 back in August. PUR1900 combines an approved anti-fungal medication with iSPERSETM to effectively bring to the lungs a medicine used to cure pulmonary fungal infections in CF patients.

During 3Q2016 financials release, the company reported the election of Dr. Matthew Sherman to its Board. Dr. Sherman is a board certified doctor in medical oncology and internal medication and has held numerous positions at Harvard Medical School. He brings to Pulmatrix a broad background and experience in drug advancement, regulatory affairs and clinical research.

Pulmatrix released new report on PUR1900 at the famous North American Cystic Fibrosis Conference. The poster presentation matched the activity of PUR1900 to the oral reference medication and measured the product deposition in the lungs compared to systemic levels to indicate the products potential benefits in treating CF subjects with fungal infections.

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