In this engaging episode, David Hough shared key updates following PaxMedica's recent meeting with the FDA, highlighting pivotal achievements such as:
FDA discussion of PaxMedica's data from the PAX-HAT 301 Study and comprehensive nonclinical programs.
PAX-HAT-301 study confirmed as positive evidence for African Sleeping Sickness treatment, expected to result in substantial time and resource savings for PaxMedica.
FDA acknowledgment of PaxMedica's comprehensive nonclinical program, including safety...
In this engaging episode, David Hough shared key updates following PaxMedica's recent meeting with the FDA, highlighting pivotal achievements such as:
- FDA discussion of PaxMedica's data from the PAX-HAT 301 Study and comprehensive nonclinical programs.
- PAX-HAT-301 study confirmed as positive evidence for African Sleeping Sickness treatment, expected to result in substantial time and resource savings for PaxMedica.
- FDA acknowledgment of PaxMedica's comprehensive nonclinical program, including safety pharmacology, ADME, and toxicology studies.
- Waivers granted for the thorough QT/QTc studies, affirming data relevance to the patient population.
- 2024 NDA submission anticipation underscores PaxMedica's commitment to neglected tropical disease treatments.
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