Inkampani phambilini yamemezela ngo-Okthoba 20, 2021 isikhungo somtholampilo esibekwe yi-FDA ocwaningweni. Inkampani inikeze isibuyekezo ngalolu daba ngoNovemba 18, 2021 futhi yathumela isichibiyelo ku-FDA ngesicelo se-Investigational New Drug (IND) ngomhla ka-9 Disemba 2021. Ngesaziso esitholwe kuleli sonto, i-FDA yasusa ukubanjwa komtholampilo futhi yeluleka. Zama ukuthi iqhubeke nesifundo.
Ephawula ngale ntuthuko, uSihlalo kanye ne-CEO uGreg McKee uthe, “Sijabule ukuqhubekela phambili nesivivinyo sethu seSigaba 2a sokuphazamiseka kokudla ngokuzitika ngobudlelwano bethu neNyuvesi yaseFlorida. Inkhulumomphendvulwano yethu ne-FDA ibe nomkhiqizo futhi ithuthukise ngokuphusile ukwakheka kwalolu cwaningo. Lokhu kumelela ucwaningo lwesibili lomtholampilo ngo-2021 esithole ukugunyazwa yi-FDA ukuthi siluqale.”
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The Company provided an update on the matter on November 18, 2021 and submitted an amendment to the FDA for the Investigational New Drug (IND) application on December 9, 2021.
- Through the notice received this week, the FDA removed the clinical hold and advised Tryp that it can continue with the study.
- Commenting on the development, Chairman and CEO Greg McKee said, “We are excited to move forward with our Phase 2a clinical trial in binge eating disorder through our partnership with the University of Florida.
