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PolyPid Ltd. (PYPD)
NASDAQ:PYPD
Standard Of Care (Soc), D-Plex
Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
Phase III
Completed
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
May 27, 2020
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Standard Of Care (Soc), D-Plex
Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
Phase III
Completed
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Jan 06, 2020
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does PolyPid Ltd. (PYPD) have in its pipeline
PYPD is currently developing the following drugs: Standard Of Care (Soc), D-Plex, Standard Of Care (Soc), D-Plex. These drug candidates are in various stages of clinical development as the company works toward FDA approval.