Not quite what FDA said.
QNTA already has done animal toxicology studies.
The FDA requested "TWO ADDITIONAL STUDIES".
FDA Accepts COVID-19 Clinical Study and Advises on Next Steps for Pre-IND Filing by Medolife Rx
As the Company expected, it received a detailed response from the FDA on its Pre-IND originally filed on April 27, 2020. The response included: recognition from the FDA on the therapeutic effects of Escozine®, validation of the Company’s clinical trial as an informal proof-of-concept study, and laid out very specific guidelines for the next steps required by the regulatory body in order to garner approval for Escozine® as a treatment for COVID-19.
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.
