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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 as a vital regulatory validation of the novelty of our PLEX generation and the main 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 SHIELD I Phase 3 Clinical Trial of D-PLEX100 for the prevention of post-surgical abdominal incisional infections, and look forward to provide a safe and effective solution for surgeons and their patients as soon as possible.”
About D-PLEX100
PolyPid’s main candidate product, D-PLEX100, is a new candidate product designed to supply local antibacterial activity spread directly in the operating room to save your ISS. After the operation of D-PLEX100 in the operating room, the generation of PLEX Array allows the prolonged and constant release of the broad-spectrum doxycycline antibiotic, resulting in a maximum local concentration of the drug for up to 4 weeks for ISS, saving lotion, with more chances of treating the antibiotic resistant to bacteria in the Surgical D-PLEX100 Array gained two FDA Qualified Product Designations for Infectious Diseases (QIDP) to save the portion of the surgical D-PLEX100 infection of the post-cardiac sternal wound and to save the portion of the abdominal incisional infection after surgery.
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
This press release includes forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expect,” “anticipate,” “try,” “project,” “believe,” “search,” “estimates,” and similar expressions or diversifications of the words with which prospective statements are intended to be identified. For example, PolyPid uses forward-looking statements in this press release when discussing D-PLEX100’s perspective to save you ISS, time, topic and frequency of communications with the FDA, whether D-PLEX100 will be eligible for a continuous review of your NOA and/or its fda precedence review, and provide a safe and effective solution for surgeons and their patients as soon as possible. Because these statements relate to long-term occasions and are based on PolyPid’s existing expectations, they are the subject of various dangers and uncertainties. In addition, PolyPid has earned the Fast Track designation for the D-PLEX100 by saving infections at the surgical site, it cannot guarantee that it will be able to retain this designation for reasons beyond its control. PolyPid’s actual results, functionality, or accomplishments may differ materially from those described or implied in the statements contained in this press release. The forward-looking statements contained or implied in this press release are the subject of other dangers and uncertainties, adding those discussed in “Risk Factors” in PolyPid’s final prospectus dated June 25, 2020, filed pursuant to Rule 424 (b) (4) (4) with the Securities and Exchange Commission (“SEC”), and in any forthcoming filings with the SEC. Unless otherwise required by law, PolyPid assumes no legal responsibility to publicly publish any review of such forward-looking statements to reflect occasions or cases after the date of thereafter or to reflect the occurrence of unforeseen occasions. References and links to Internet sites have been provided for convenience, and the data contained on those internet sites is not incorporated by reference in this press release. PolyPid is not to blame for the content of third-party websites.
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