General discussion, page-15257

Welcome aboard @CrimsonSky

A great premlimary summation on IHL.
I would suggest just a couple of tweaks.

"treatment of Generalised Anxiety Disorder which are both undergoing phase 2/3"
PSI GAD is currently part way through an Australian Phase 2 POC Trial (Phase2) and is a few months to a year behind IHL42X which is preparing for a Pivotal Phase 2/3 Clinical Trial in the United States having already completed it's POC Phase 2 Trial in Australia (UWA) last year.

"PSI-Gad is the use of psilocybin (which will be allowed to be prescribed as medicine this coming July) "
The latest news from the TGA did allow for Psilocybin to be down-scheduled but not for the treatment of GAD.
" The Delegate decided to limit prescribing of psilocybin and MDMA as a Schedule 8 drug to treatment-resistant depression and post-traumatic stress disorder. This is because there is only sufficient evidence that the substances will be beneficial for these conditions."
https://www.tga.gov.au/resources/publication/scheduling-decisions-final/notice-final-decision-amend-or-not-amend-current-poisons-standard-june-2022-acms-38-psilocybine-and-mdma/re-scheduling-psilocybin-and-mdma-poisons-standard-questions-and-answers

It is unclear at this point from Incannex's perspective on how IHL will navigate this TGA decision, but an interesting article was authored and published over on the other thread it's a good read
https://theconversation.com/the-tga-has-approved-certain-psychedelic-treatments-the-response-from-experts-is-mixed-199290?utm_medium=Social&utm_source=Twitter#Echobox=1675806853

Yes psilocybin will be able to be prescribed from July under certain condtions but not for IHL's GAD program.

TIME SAVERS for IHL-42X
The trials are progressing well and the lead contender ATM is IHL-42X and the BOD has set aside 12 months for the Phase2/3 Trial.

>> A combined Phase 2/3 clinical trial is a clinical study that combines the characteristics of both Phase 2 and Phase 3 trials. In this type of study, the initial stage (Phase 2) is used to evaluate the safety, efficacy, and dosage of a new drug or treatment, while the later stage (Phase 3) is used to further test its safety and efficacy by comparing it to the standard of care or placebo in a larger number of patients. The main purpose of a combined Phase 2/3 trial is to reduce the time and cost involved in conducting separate Phase 2 and Phase 3 trials, as well as to gain more comprehensive information about the new drug or treatment.

In comparison, a Phase 2 clinical trial is an intermediate stage of clinical testing that is designed to evaluate the safety and efficacy of a new drug or treatment in a small group of patients. The main objective of a Phase 2 trial is to determine the optimal dosage of the new treatment and to gather additional information about its safety and efficacy, so that a larger, more comprehensive Phase 3 trial can be planned.

>> Using the 505(2)(b) Pathway will shave months if not years off the normal trial timeline.

The FDA 505(2)(b) pathway is a regulatory pathway for the approval of new drugs in the United States. It is a part of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and is used to approve new drugs that are similar to already approved drugs, but have some differences in their formulation, route of administration, or indication.

Under the 505(2)(b) pathway, a new drug application (NDA) can be filed with the FDA, and if the FDA determines that the drug is similar to a previously approved drug and has the same active ingredient, it can approve the new drug based on the safety and efficacy data of the previously approved drug. The 505(2)(b) pathway is often used for drugs that are generic versions of already approved drugs.

In order to use the 505(2)(b) pathway, the applicant must demonstrate that the new drug is safe and effective based on data from the previously approved drug, as well as from any additional tests that may be required. The FDA must also determine that the new drug is adequately manufactured and meets the requirements for good manufacturing practices.

>>The 505(2)(b) pathway provides a faster and more cost-effective route to approval for new drugs, and can result in earlier access for patients to new and potentially life-saving treatments

>>In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals. In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.
https://stocknessmonster.com/announcements/ihl.asx-3A593717/

Good luck @CrimsonSky