PAA did no preclinical work for the open ended Fight MND funded...

PAA did no preclinical work for the open ended Fight MND funded trial, it was an escalating dose phase 1 trial to test tolerability. The evidence we had was all 12 patients alive and stable. No deaths!!! According to Berry consultants to have all 12 patients survive was at least a 1000 to one chance, more now'

"PharmAust initially submitted the request for ODD to the FDA’s Office of Orphan Products Development early in
November 2023. In January 2024, the FDA responded, requesting further supporting data, either preclinical or
clinical, to establish the drug's potential for effectiveness in MND/ALS" from herehttps://investorhub.pharmaust.com/announcements/6245858

With in a couple of months from the start of the trial it was evident that Monepantel was well tolerated and appeared effective in stabilizing MND.
Top line results from the MEND study here https://investorhub.pharmaust.com/announcements/6219219