The Great Pharmaust FDA ODD Approval Sweepstake, page-162

I will start with - someone has my date so …. I will just watch from the sidelines and acknowledge I was slow and it’s my own fault.

Now the fun part:

Assuming the intention is to start the trial in H1 because they said that.
Assuming Prof Mathers will be first cab off the rank (Monash Uni) because she is our lead pilot!
Assuming NSW / Prof Dom and any other AU site will follow because it is logical.
Assuming trial starts in AU because we know that.
Assuming they need the IND to get the trial started because they do.
Assuming that START means trial approved and recruitment can commence (but potentially no one actually on / maybe sites preparing to run the trial and screening preps)

Working backwards for 1 July ……(first day of H2)

27 June - Macquarie HREC meeting for June
17 June - Submission for Macquarie HREC
6 June - Monash HREC meeting for June
22 May - Submission for HREC Meeting
(need IND)
22 April - (too late really) Submit IND (30 day process)
April / May - the latest to have funds to execute trial to support HREC
20 April - realistically too late for ODD (to minimise costs of submitting IND)

What this tells me is that things are about to get funky…

It tells me the company expects / hopes (because they have zero control over a US of A govt dept!) to get ODD VERY soon. ODD is critical to predict funding needs and trial structure/timing.

Funding - Michael/PharmAust has primed the market for AUD$20-30M cap raise (ish).

But what we don’t know is what it does/doesn’t take into account (because I don’t think they should or did count chicken before they hatch, publicly anyway)

Significant variables:
- grant from FightMND
- any other funding from FightMND
- ODD cost reductions
- implications on costs, speed & decision timing of EU equivalent to ODD (I doubt this will land prior to cap decision)
- distribution / forecast of costs per trial location
- Healey platform arm or not … (I think more likely than not)
- EU and Tricals and related benefits (if any)
- how much more oppie holders will tip in to minimise cap raise.
- Other funding sources that could present from any number of avenues other than a market CR.

So they need to get a grip of a HEAP of stuff right now to know more realistically how much to raise then act very soon!

A whole heap about to happen should they genuinely believe they can start in half 1 of Calendar year 2024

adreamer