Regarding SPECULATION as to Good or Bad results for IHL-42X,
I would suggest it might be reasonable to
review the BOD's actions during the past few months to get a sense of where the OSA Trial maybe be heading in the future.
Action A. Open-Label Extension Study - Not required if prelim negative results
Action B. Using Data from Alfred Trial to support the International Patent Application - Not required if prelim Negative Results
Action C. Additional Study at UWA - Not required if prelim Negative Results
Action D. Dual Locations studies for further evidence to advance FDA approval - Not required if prelim Negative Results
Action E. Incannex engages Procaps to manufacture IHL-42X soft-gel capsules in preparation for pivotal clinical trials. Not req if prelim Neg Results
Action F. Preparation of PRE-IND FDA meeting package with aim of a meeting with FDA for Q1, 2022. - Not Required if prelim Negative Results
Action H Listing on the NASDAQ to coincide with the release of results from our IHL-42X - Not required to coincide, NASDAQ Listing, if prelim Negative results
Action I Appoint New York Based PR firm to represent/arrange for Medical Conferences - Not Required right now, if prelim Negative Results
Action J Setup USA Office strategic stakeholder engagement with clinical research facilitators, regulatory authorities, and the investment community - Not Required right now, if prelim Negative Results.
Action K CEO move to USA to set up our US office and networks - Not Required right now, if prelim Negative Results
As our friend
@1ncog has pointed out that some actions could have been for the group as a whole and not necessarily just for IHL-42X. BUT my point is there would be no urgency to set up an office in the USA or appoint a PR team for IHL and waste those resources if there were not some requirement "IMMINENTLY".
What if the BOD had some control over when the Novotech Report was released.?? The BOD could get all their ducks aligned in advance ??A. Submitted prelim results from the Alfred Hospital to support the Patent Application (Early last Year)
B. The Novotech Report appears to have some intervals of consultation with IHL (More Recently)
>1st Draft Review
> 2nd Draft Review
> Final Sign-off
Here is part of the Novotech Contract with IHL. (Review Paragraphs 92,93,94)
https://docoh.com/filing/1873875/0001213900-22-003395/IXHL-20FR12B/file/14As per
@FreeBobby2002 consultation with Management leading up to the final report is normal.
As for the Trial Results - How successful?There have been studies that already show that dronabinol reduces the severity of OSA by 30%10-15% improvement is considered by medicos to be "clinically significant".The issue with using dronabinol as a treatment for sleep apnoea is that it still displayed some level of impairment in the patient because as you are aware dronabinol is a synthetic form of THC.The challenge for Incannex was to create a formulation in IHL-42X that achieved the two goals> Reduce the level of severity of OSA in patients and> Reduce the amount of dronabinol so as to fix the breathing issuesbut not give the patient so much (dronabinol) to prevent them from driving or operating and function normally the next day.IMO the Phase2 Trials have been dosing patients to find the optimal dosage to achieve these goals.
We might be surprised to see results that are> greater than 30% reduction in the severity of OSA levels and> with reduced dronabinol to a level where it is safe to function normally.
Looking forward to learningAbout some Trial SuccessAn update on the FDA Pre-Ind meeting/scheduleFuture Phase 2 / 3 Trials Locations of future trials and timeframes.
GLAH - Patience for Success 
A special thanks to
@tossydog,
@comincon,
@ime003 for recent chats
