What an excellent day yesterday was.I sense that the substantial...

What an excellent day yesterday was.

I sense that the substantial selling off the back of excellent news indicates we have dodged a bullet yesterday, at least for those LTH who wish to build an enduring biotech company.
Perhaps the catalyst of ODD is now unlikely to deliver the outcome that was previously expected by some key holders ( ie. sale ).
Pure speculation of my behalf.

However, yesterday we did learn FACTUAL information about the substantiate progress of the company.

- PharmAust was granted Orphan Drug Designation by the FDA for monepantel and its treatment of Motor NeuroneDisease.

- A new Chairman was appointed, Sergio Duchini. Sergio comes with a wealth of experience, and is also the current chair at Lymphoma Australia.

- PAA will continue with new board and management hires, which given John referred to himself as interim CEO in this presentation, will include a new CEO, to be appointed by Sergio and the new board.

- Regarding the OLE study

- 10 patients have been recruited - all 10 continue to tolerate monepantel VERY WELL
- the 11th, and final patient, will be enrolled in the study over the next 2 weeks.
- PAA will then use Berry Consultants to update the market on ALSFRS-R scores and Survival Analysis of these 11 patients.

- Regarding the ALS STRIKE Study ( we have a name for the phase 2/3 trial ).

- the SAB have contributed to design of the STRIKE study.
- the first patient dosed in ALS STRIKE study will be in Q3, CY 2024.
- which is turn means funds will have been raised, for the Australian arm of the study at a minimum, and a bevy of clearance's to be granted for the study by various representative bodies over the next few months.
- we are using NEALS in the USA to conduct the ALS Strike Study ( https://neals.org/ )

- We have committed funding to pre-clinical studies to better understand MPL potential effectiveness against other neurodegenerative indications, to assist in identifying the next target indication.

WOW !

So what does all of this mean ( back to speculation ).
BTW, I thought John was great on the Aus Biz interview.

Funding

John indicated there was plenty of interest in funding ALS Strike, particularly now that we have ODD ( Aus Biz interview ).
I think the appointment of Sergio would have settled the nerves of FightMND and others, and the team will only get stronger from here.
Likely odds on to get FightMND funding announced as part of The Big Freeze.

OLE Study

Fully recruited by end of May.
Report on ALSFRS-R scores and Survival Analysis by mid-June, maybe in conjunction with FightMND announcement in mid-June.
Great opportunity for major PR push and likely to create a value inflection point for PAA.

Board & Management

- two more key board appointments, and a new CEO
- setting up a strong team to take MPL forward. This may or may not include MT, but with ODD and the results at hand I have no doubt PAA will be able to attract the strongest of candidates ( we attracted MT , for example ! ).

New Indication

- this is the left field value catalyst over the next few months IMHO.
- identify the indication (eg. Parkinson's Disease ), approach an organisation like the Michael J Fox Foundation with pre-clinical data to fund a phase 1 trial, confirm scientific party to conduct the phase 1 study - announce to market.

Yesterday, IMHO, really was the new dawn for PAA.