Ann: Commencement of Cohort 3 in Phase 1/2 MND Trial, page-151

What a load of rubbish.

Three years ago something big happened - the covid pandemic and everyone's plans were thrown out of the window.

Imo covid side-tracked PAA's program and disrupted everything, everywhere. As I said at the time - I thought the whole covid thing a moonshot. Then none other than WEHI professor Peligrini who tested it pointedly warned us at the covid webinar,"that it was a long pipeline". What happened subsequently completely vindicated my intuitio and Professor Peligrini's warning.

The other problem that emerged simultaneously was that Elanco decided to walk out on its option for the dog pill, upsetting all plans. There was also the issue raised by the first phase II (a) dog trial of monepantel's newly discovered bi-phasal nature which would require fine tuning of the pills and dosages in another trial. This would also be vital for any planned human cancer trial.

So behind the scenes, PAA began working on MND in the lab as a possible alternative route to approval and commercialisation. So far that's gone well as the newly fine tuned pills have passed the pharmacokinetic tests in this MND trial and that opens up the way for human cancer trialing.

But now the question that remains, does monepantel have a positive effect for patients with MND? There's no guarantee of that of course, We're waiting for clues from the current lab tests that we were told one patient who started with the first cohort seems to have been stable and after all this interim analysis half way through the trial that was requested by the Principal Investigator who is an experienced practioner in treating MND patients, nevertheless the decision has been made to continue the trial with cohort 3 instead of waiting for these lab results. The trial is still only at the halfway mark, in case people have forgotten.