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davefb

407 Posts.

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02/09/22

16:42

Post #: 63490886
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Originally posted by thevinnys: ↑

Mid - QTR Update - Last Update 31/7 some nice updates since then;

The next most immediate news update will be the FDA PRE-IND Meeting for IHL-216A ( Concussion & TBI ) more details as follows

IHL-42X - Sleep Apnoea - (Pipeline #1)
Expect updates on;
> Most interesting will be locations/partnerships with IHL-42x phase 2/3 trials.
> No toxicology studies required and accelerated process via 505(b) (2) pathway.
> Next steps for the development of IHL-42X includes the finalisation of clinical trial designs
> Arrangement of operational imperatives necessary to open an investigational new drug application (‘IND’) with FDA.

IHL-675A - Wonder Drug - Inflammation (Pipelines # 2,3,4)
Expect updates on;
> Incannex received approval from the Human Research Ethics Committee (HREC) to commence a phase 1 clinical trial investigating IHL-675A in humans for the first time.
> C-Max S.A enrollments called for to commence trial Phase 1 around the ~~end of August,~~next Tuesday 6th September.
> We may see some trial results by end of the year. "Expect trial to completed by the back-end of the year" Joel Podcast 9/5/22

https://www.cmax.com.au/current-trial/cm7121/

IHL-216A - Traumatic Brain Injury - (Pipeline #5)
Expect updates on;
> Pre-ind with FDA for TBI - Q3 - 2022 ( by end of this month ) to discuss the Company’s intention to conduct an expedited clinical trial program required for a new drug application and marketing approval.
> IHL-216A drug formulation development required for in-human studies is also nearing a conclusion following an extensive research and development process commenced in June 2021. ~~(Vectura - Inhaler update?)~~ BIG Update on this formulation as follows;
• Incannex has engaged Curia to scale up cGMP fill-finish manufacture of IHL-216A
• Engagement of Curia follows the achievement of “proof-of-concept” formulation development (Vectura )
• The first cGMP batch of IHL-216A manufactured at Curia will be used in phase 1 clinical trial (ASX August 2nd)
https://stocknessmonster.com/announcements/ihl.asx-3A598294/

PSI-GAD - Monash Uni Partnership (Pipeline #6)
Expect updates on;
> Phase 2a results for the psi-gad program from Monash Uni partnership,
> 22 participants are enrolled in the trial and the remaining 8 participants are anticipated to be enrolled during the current quarter.
> Current Trial "Data read-out by the end of the year" Joel Podcast 9/5/22
> New Updates expected on the research agreement/s for other Anxiety Indications with Monash using VR Incannex and Monash are in advanced stages of discussion in relation to a research agreement for the clinical trials required to develop the new treatment form. The initial clinical trial will assess the efficacy, safety, tolerability, and optimal dose of the treatment method.
> Patents for PSI-GAD are in the "Drafting" stage per ASX - 9th August
Expect updates on;
News is pending concerning new staff appointments as highlighted by@rhino78
"The thing about Joel and the IHL board is that they don’t take backward steps or down grade, so I would be expecting they appoint a new board member at some point with the skills and contacts to help us take the next big step fwd.~~In my mind, if IHL can get a board member with contacts in big pharma and or experience in bringing blockbuster drugs to market, we are well and truly on the way to where we all want to go."~~ Great foresight and post there from @rhino78
Expect more updates on the appointment of Bob Clark as a new Director as per ASX 17th August https://stocknessmonster.com/announcements/ihl.asx-3A599204/
• Highly experienced pharmaceutical executive with 20+ years at Pfizer and 10+ years at Novo Nordisk
• Secured FDA registration and marketing approval for 12 significant new drugs in the past 10 years at Novo Nordisk in his capacity of Vice President – US Regulatory Affairs
• Personal leadership of more than 15 successful US FDA Advisory Committee Meetings on behalf of Novo Nordisk and Pfizer
• Nationally recognized expert on FDA/EMA liaison interactions and US pharmaceutical advertising and promotional practices
• Documented success with FDA accelerated approval programs including Fast-Track, Orphan Drug, Breakthrough Therapy Designations, and Priority Reviews.

Bob's experience will be very useful in the following;

> The PSI-GAD program has a break in its Phase 2A trial by the end of this year to;
1. Assess the data so far for the first 30 of 72 total participants
2. Lodge an IND with the FDA. (early 2023 maybe)
The results thus far may warrant Bob's experience in lodging the IND

> IHL-216A ( Concussion & TBI)
1. A Pre-IND meeting has been requested for this current Quarter for feedback on the
development program for the next Phase One Clinical Trial.

> IHL-42X (Sleep Apnoea)
1. Opening an IND in the coming weeks and months to commence the next Phase 2/3 Clinical Trial.

>IHL-675A ( Wonder Drug )
After completion of Phase 1. Clinical Trials by the end of the year, (subject to success)
** a Pre-Ind will be needed separately for 2023 for
1. Rheumatoid Arthritis
2. Inflammatory Bowel Disease
** a PRE- IND will not be needed Lung Inflammation (Pre-IND completed)

Expect further Valuation Research Reports as Clinical Trials Progress
> Expect also further news on APIRX developments as they are combined into the group as per Recent Research analysis from the Edison Group
https://www.edisongroup.com/publication/addressing-unmet-needs-via-alternative-approach/31265/
> Interesting to note that the Edison Group valuation is based on the US Market penetration alone and...
> "We ascribe92% of the company’s valuation to IHL-42X,1% to psilocybin, and 7% to cash.We have not included the earlier-stage assets IHL-675A or IHL-216A in our valuation;however, we will revisit our valuation following clinical progression of these therapies." Currently, the SP could go 3X to align with this conservative valuation. per"Edisons Valuation: US$695.7m or US$11.42 per ADR. For the Aussie investors that is 66c."Top 20 UpdatesDue in the next week or so in the Annual Report, I have been tracking ETF Group purchases they are holding now up to 50 M shares now from around 43-45M.
We should see Dr George Anastassov and Mr Lekhram Changoer in the Top 20 ?? The stakeholders of APIRx (‘sellers’) have been issued 218,169,497 new shares in IHL (ASX August 5th.)

Updated Balloons for those interested
CLICK TO ENLARGE THE IMAGE
GLAH Have a great Weekend

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Dude. Absolutely love your work.

IHL Price at posting: 23.0¢ Sentiment: Buy Disclosure: Held
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