The FDA’s Fast Track designation is a procedure designed to facilitate progression and speed up drug screening to treat serious and life-threatening situations and meet an unmet medical need. The Fast Track designation allows early and common communication with the FDA about drug progression and the review procedure, and allows continuous review of the application for a new drug (“NDA”) from a D-PLEX100. It also allows eligibility for expedited approval and precedence review, if applicable criteria are met.
“Receiving the FDA’s Fast Track designation represents a vital achievement for our promising D-PLEX100 progression program,” said Amir Weisberg, CEO of PolyPid. “We consider the Fast Track designation to be a vital regulatory validation of the novelty of our PLEX generation and the increased unmet clinical desire that exists lately in the ability to save surgical site infections in complex surgical contexts such as abdominal surgeries. We recently introduced our D-PLEX100 SHIELD I Phase 3 Clinical Trial to prevent post-surgical abdominal incisional infections and anticipate to provide a safe and effective solution to surgeons and their patients as soon as possible.
About D-PLEX100
About PolyPid
PolyPid is a clinical Phase 3 biopharmaceutical corporation aimed at the progression of targeted, locally administered and long-release treatments, its patented PLEX (Polymers-Lipid Encapsulation MatriX) generation. PolyPid candidate products are designed to treat diseases with unsatisfied medical best wishes by combining PLEX with drugs to administer them directly to express framework sites at predetermined release rates and for periods of several days to several months. PolyPid’s main candidate product, D-PLEX100, is in phase 3 clinical trials for the prevention of sternal and abdominal ISI. PolyPid’s generation and products are based on the inventions of Dr. Noam Emanuel, the company’s founder and clinical director.
For more information about the company, www.polypid.com.
Forward-looking statements