General discussion, page-4392

Very Interesting !!!

Not sure if anyone has pickup on the recent announcement details concerning IBD and the proposed FDA pathway

This part...
Incannex will now expand its discussions with research organisations and regulators to continue a
clinical and regulatory strategy and these negotiations are ongoing. In particular, it is anticipated that the US
Food and Drug Administration (‘FDA’) 505(b)(2) new drug application pathway will be applicable to the IBD
indication. This is in addition to the FDA pre-IND submission undertaken for the SAARDS indication, as
detailed in the announcement titled “Positive IHL-675A in vivo results and FDA Pathway” released on the
23rd of November 2020.

There appear to be some significant advantages taking this route with the FDA....

Product Planning (Click here to view article )

Note it is not under under the 505(b)(1) pathway but 505(b)(2)

“Traditional” new drug development and approval—generally required for a new chemical entity drug that has not been approved before or that doesn’t have a significant marketing history in the U.S. or elsewhere—takes place under the provisions of section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act. When it comes to 505(b)(1), the passage from “promising molecule” to “approved drug” is long, difficult, risky and expensive. Typically, achieving drug approval under the 505(b)(1) pathway—which requires the completion of new studies to establish the safety and efficacy of the drug in a specified disease or condition—can cost the sponsor up to 15 years and a billion dollars.

Because a 505(b)(2) product can rely in part on the FDA’s previous findings on the safety and efficacy of an active ingredient as well as data available in the public domain, at this product planning stage, a potential developer of a 505(b)(2) should seek ways to weave such existing data into the product’s development strategy to reduce its size, scope, timeline and, therefore, cost. In addition to representing a faster, less expensive path to market, products approved under the 505(b)(2) pathway can also sometimes qualify for several types of market exclusivity such as orphan drug exclusivity (seven years), new chemical entity exclusivity (five years), “other” exclusivity (three years for a “change” if certain criteria are met), and pediatric exclusivity (six months added to existing patents/exclusivity).The accelerated path to approval and prospect of exclusivity make 505(b)(2) a cost-effective and commercially attractive route, but one with key differences from traditional 505(b)(1) development.

BENEFITS OF 505(B)(2)

505(b)(2) is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that
eliminates most nonclinical studies as well as extensive safety and efficacy tests.
Relatively lower risk because of previous drug approval
Lower cost,
accelerated development due to fewer studies
May qualify for three, five or seven years of market exclusivity

Read This article

This Board continues to kick goals....

GLAH