Escozine / Quanta - LARVOL DELTA

FDA Accepts COVID-19 Clinical Study and Advises on Next Steps for Pre-IND Filing by Medolife Rx (GlobeNewswire) - "Medolife Rx, Inc....received a response from the U.S. Food and Drug Administration (FDA) relating to its Pre-Investigational New Drug (Pre-IND) filing on its lead drug candidate Escozine®...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...FDA has requested that the Company complete two additional toxicology studies in animals....The Company plans to commence the additional toxicity studies requested in the response in the coming weeks with a short completion timeline. After that, the Company will file the data to the FDA, once again seeking approval of its Pre-IND, moving the Company closer to approval."

FDA event • Infectious Disease • Novel Coronavirus Disease