General discussion, page-17700

We still appear to be on track with PSI-GAD! At least...

PSI-GAD
Completed dosing, I am still expecting an update on results in the new year Q1

IHL-42X BA/BE Study @ C-MAX - Adelaide (Delayed by HREC approval - 4 months)

• Primary Compl due Feb 2024 and Study Compl Date April 2024
• New projections based on original published timelines plus 4 months.
• https://classic.clinicaltrials.gov/ct2/show/NCT05857384?term=incannex&draw=2&rank=2
• Enrollments are advertised for commencing Thursday 5th October.
• https://www.cmax.com.au/current-trial/c03422/

IHL-42x Blended phase 2/3 12 month patient study - (Awaiting latest update)

• IHL submitted the IND application on 20 July 2023
• IND reviewed by FDA and IND-opening clinical trial is deemed safe to proceed ASX 22nd August
• https://stocknessmonster.com/announcements/ihl.asx-3A623774/
• This trial is being managed by Fortrea - CRO https://www.fortrea.com/
• "Fortrea’s familiarity with the study and established relationships with potential trial sites will expedite the study start-up and site

engagement activities.” CEO

• https://stocknessmonster.com/announcements/ihl.asx-3A621739/
• It's just over a month since we got the "Go AHEAD" from the FDA.
• more time is most likely needed for Trial Site Appointments....actual enrolments.....and a start...
• @ime003 Joel reported it could be 6 months before the trial starts from the Brisbane meetup.

IHL-675A (R/A) Original timelines...

• HREC approval 13th July https://stocknessmonster.com/announcements/ihl.asx-3A621584/
• Estimated Study Start Date: July 2023
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: December 2024 https://classic.clinicaltrials.gov/ct2/show/NCT05942911?term=incannex&draw=2&rank=1
• Last announcement https://stocknessmonster.com/announcements/ihl.asx-3A622123/
• Pre-IND with FDA positive, there may have been some tweaks to the trial design
• Awaiting on update

Clarion Clinics

• The website states opening soon https://clarionclinics.com/
• Adjusted from "by end of Q3" (end of September)
• As @ime003 mentioned this Regulatory "Green Light" to open, is beyond IHL's control.
• @moguns has reported that the Clinic looks like it has reached practical completion and is ready to go. "I stopped by the clinic again yesterday. Just final touches now, art on walls etc." https://hotcopper.com.au/threads/ihl-incannex-holders-research.6278647/page-1007?post_id=69888325
• a waiting game....

Re-domicile

• CEO is currently in NY
• View the published re-domicile timeline here on page 38 https://stocknessmonster.com/announcements/ihl.asx-3A621403/
• If the Federal Court Filing has been passed then the next step is the mail out to shareholders.
• It's been posted that JL is meeting in NY with Analysts / Investors, I can't imagine he would not be meeting with George and Bob & re-domicile updates too.
• Email from Joel regarding NASDAQ requirements thanks for taking the time to email @rusty02 "The minimum listing price on the NASDAQ is $1, we are well above that with our proposed ratio and the aim is to continue to be well above that leading into the redomicile. We do not expect any issues with the listing requirements with the NASDAQ in this regard."

Click on any of the links for the resources outside of Hot Copper.
If someone is interested in the latest unpublished information they could email management.
Posters.....thanks very much for posting Joel's email updates & the noodle lady's updates too, it used to be the horse whisperer!!! haha!

Good luck to all holders