This announcement goes someways to alleviate the concerns of some recent investor commentary
regarding the IND Opening with the FDA for IHL-42X. If there was an issue with filing the IND, as the recent commentary mentioned then the appointments today would not have occurred.
https://fstrials.com/about/
https://www.neurotrials.com/atlantaresearchinvestigators.htmlIn general, the appointment of principal investigators (PIs) for clinical trials is typically done before or during the planning stages of the study, rather than specifically tied to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). The selection of a PI is an important step in the process of designing and conducting a clinical trial.
The PI is usually a qualified physician or researcher who takes responsibility for the overall conduct of the clinical trial at a specific site or multiple sites. The PI is involved in various aspects of the trial, including protocol development, participant recruitment, study oversight, data collection, and reporting of adverse events. They are responsible for ensuring that the trial is conducted in compliance with the study protocol, applicable regulations, and ethical standards.
Prior to initiating a clinical trial, sponsors or research organizations typically identify and appoint PIs based on their expertise and experience in the therapeutic area of the study. The selection of PIs is important for the successful implementation of the trial, as they play a crucial role in overseeing the scientific and ethical aspects of the research.
Regarding the filing of an IND with the FDA, it is typically the responsibility of the sponsor or the organization initiating the clinical trial. The IND is submitted to the FDA to seek permission to conduct a specific investigational study in humans and includes information on the drug or therapy, preclinical data, study protocols, and other relevant details. While the PI's involvement is important for the IND submission, their appointment generally precedes the filing process.
So glad for the first sites to be announced.
This is a historic step for Incannex in terms of being the first Phase 2/3 Pivotal Trials.
Looking forward next to the IND Filing.
GLAH
