Evening @221022,
I'm sure most are aware the clinical hold was announced back in July (check the announcement for more detail - think it was early in the month) but I don't think anyone's overly concerned at this stage given it is purely isolated to the USA and has no bearing on trials conducted in Australia.
IRX's Aussie trials are going to be starting within the next few months and these are unaffected by US FDA clinical holds which at this stage is the most important aspect.
Having said that AFAIK once the nonclinical is completed to FDA satisfaction (which from all accounts could just be a 7 day rodent study or similar) it should unblock the clinical hold and open the IND which would be great.
You sound like you have experience with these kind of investments and clinical studies before? Hopefully IRX can execute what they are planning successfully (as most around here think they can) and it might be an attractive early entry point for yourself as well.
Cheers and best of luck,
Disco.
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