Good morning!This is a nice little update on IHL-42X and its...

Good morning!

This is a nice little update on IHL-42X and its development timeline.
This update is not focused on the FDA IND Trial but rather on;

The BA/BE study will assess the pharmacokinetics and tolerability of the two active pharmaceutical
ingredients (‘APIs’) in IHL-42X, dronabinol (‘THC’) and acetazolamide, compared to the respective FDA
reference listed drugs, as well as the effect of food on pharmacokinetics of the two APIs.

The results of this study will form a critical component of a future new drug application (‘NDA’), providing the necessary bridge to the reference listed drugs, thereby facilitating the use of historic safety data via the FDA505(b)2 regulatory pathway.

This trial at C-Max in Adelaide IMO is a study that would need to be done at some stage or other to support the FDA - IHL-42X new drug application with the FDA. ( Bridging Study)

Most importantly IMO this study is all about shortening the timeline to getting IHL-42X on the pharmacy shelves by getting on the front foot and implementing this study in parallel/prior to the larger Phase 2/ 3 study, which could potentially save months at the other end.

The 505(b)(2) Process
Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act was established by the Hatch-Waxman Amendments of 1984 to allow sponsors to obtain approval of NDAs containing investigations of safety and effectiveness that were not conducted by or for the applicant, but for which the FDA has issued an approval. The section was added to avoid unnecessary duplication of studies already performed on the reference drug. However, sponsors must still provide any additional data necessary to ensure that the differences from the reference drug or other existing information do not compromise safety and effectiveness.

Today, 505(b)(2) can provide relatively fast-track approval for a wide range of products, especially for those that represent a limited change from a previously approved drug. Ideal candidates include:
• New indications
• Changes in dosage form, strength, formulation, dosing regimen or route of administration
• New combination products (like IHL-42X)
• New active ingredients
• Pro-drug of an existing drug
https://camargopharma.com/assets/general/whitepapers/cmrgo_whitepaperapprovalpthwy_vfb.pdf

A decrease in time to market means early access to patients and an increase in SP for shareholders.

GLAH