Ann: Quarterly Appendix 4C and Activities Report, page-54

Hi Extra,

Great post! I have some oppies to convert which I will do shortly. I don’t plan on selling these shares either.

This is a PIVOTAL trial with potentially an Accelerated Approval for FSFG at INTERIM 2 Analysis (Week 104) with the FDA in an ORPHAN STATUS designated RARE DISEASE. The poster you all are referring to is well aware of this. It’s not your average Ph3 trial. He’s stating things a lot of us already know, but it’s a special thing to be granted these possibilities not just in the USA but also the UK as well. So I’ll leave that with your thoughts Extra, but I see we are also co-invested on another stock with quite a similar story, but different.

Something that I find interesting:

So this morning I was looking back over old ANNs for a friend regarding updates on the ACTION 3 trial & since the ANN on 24/7/23 announcing that the final patient for the N=72 was randomised, this tells us that the trial retention has been good, as the dates for interim analysis have not changed since July 2023. Obviously we have had DSMB review since then also, advising the trial ongoing with no change.

Last patient data collection scheduled for 26/2/24, Results ON or AROUND 15/3/24. That gives approximately 3 working weeks, just a bit under following the Week 35 visit (as per ANN). Visits can be +/- days to a week, which is the norm (remembering these are human beings with lives to live), but obviously none of us have seen the trial protocol & usually there is a bit of leeway for visits before becoming a protocol deviation.

So I guess that is why we have been given target dates, could be a bit sooner or a bit later, so I think we should be, as investors alert from the beginning of March 2024.

Just some food for thought & looks like the selling volume has died down a bit. Could be multiple reasons why, but I highly doubt it is anything to do with Trial data leaked (discussed previously).

Have a great afternoon, almost the end of the school hols so making the most of this week, before going back to the “sh** hole” as my youngest calls it lol.