IHL 0.00% 4.1¢ incannex healthcare limited

Ann: Positive FDA Pre-IND meeting guides IHL-675A development, page-53

  1. 321 Posts.
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    It seems clear to me that because the 21st April date was published there has been accumulation by traders into that date and sellers holding off also being cognisant of that date. There was no delay, it is the 21st April right now in the US.

    To me we now know with certainty that we can pursue the 505b(2) pathway which is the most important part of the announcement as it allows the quicker path to commercialisation. The fact that the FDA has allowed all of the lung indications to be grouped as "one" under the same IND is also very significant in my mind.

    I've spoken to the company this morning and my understanding is that the Phase 1 trial will probably incorporate analysis of inflammation blood biomarkers. Therefore this is not just safety its part efficacy assessment also.

    The other thing here is that the rheumatoid arthritis results were amazing and the market is huge. HCQ is still very widely prescribed dot treatment of this condition but the toxicity can be an issue for many patients and 675A's combination appears to drastically reduce the quantity of HCQ required (by up to 90%) hence partially eliminating that toxicity issue.

    The stock has had an incredibly strong move in a very weak market in the past week so this is normal trading activity that we've seen over and over. Once the short term traders are out we'll see where we land. The more work it does in the high 20's the more likely a stronger and sustained move into the 30's will follow.

    Ted.

 
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