I agree with this take: this latest amendment almost certainly sent the message that there is enough time left before listing to either swing trade, or attempt quick gains elsewhere (for those who are so minded). This may well be a significant strategic mistake, if the following reasoning ends up being correct.
In response to your previous, also excellent post, point 4)
I understand the rationale behind the advice regarding the website publication to be that materials online should not contradict materials submitted to the SEC. To me, this does not entail a strict requirement for the SEC process to be entirely over before publication, but rather for the SEC process to be materially concluded to the point where the company knows the content of the website is in sync with information submitted to the SEC that will not change with any future amendments. In other words, Incannex will have assured itself that any remaining amendments with the SEC will not impact the information on the website.
This would mean that from the moment of the website publication, there is a string inference that remaining changes to the SEC registration application would be of a nature relating to final details such as ADS structure and price. This seems to be confirmed by the actual content difference between the previous F-1a and this most recent one. Those who sold today because they lost patience, or hoped for another swing trade, may possibly regret it since the type of update this last amendment contains could have been pre-approved by the FDA, and assuming a lengthy review process may be incorrect. If this reasoning is correct, effectiveness could happen at any moment now, potentially with a trading halt.
In response to your previous post, point 5)
The only 'error' I have detected on the website is that although the ethics approval and pre-ind for Psi-GAD exists as an announcement on the site, it is not reflected in the information provided under the Psi-GAD program section itself. That section must have been designed prior to the announcement, and was not updated.
https://www.incannex.com.au/clinical-trail/psi-gad/
Development tab.
The chart difference you noted is indeed explained by the US-centric nature of the SEC filing and US investors targeted by the prospectus. My understanding is that any foreign clinical trial that is not undertaken under an FDA IND, must be reviewed and have its data validated by the FDA before it is accepted as fulfilling the requirements of any of the phases. Until this has taken place, Incannex has correctly displayed none of the US phases as completed. We should, on balance, be optimistic that most or perhaps all of the clinical trial data accumulated by Incannex in Australia will be validated by the FDA when the time comes to transition into the FDA track: Incannex has sought excellent guidance for their trial design, including of course from the FDA itself.
For instance, at the conclusion of the OSA phase 2b trial at the end of the year, I anticipate the trial results will be submitted to the FDA for validation, and the result of that process will determine where that drug development program ends up in the FDA phase chart.
This matter is really important: thank you for asking the question, and if I have provided an incomplete or unsatisfactory answer, I hope other voices will correct and/or complete the picture further!
Onwards!
