Well you would be right with that comment Peetee .
Over the hump in March now , heading towards April ,,, Plenty of green shoots showing on Friday so hoping this week continues to strengthen the green positions.... This time last year PAA had just applied for ODD ,,, and as we know had that Granted so even more of a surprise not be be given the Phase II IND Green light??
March 14 2024
PharmAust files positive clinical data with FDA to support
Orphan Drug Designation request
Highlights:
• Clinical data showing monepantel has the potential to delay the progression of MND/ALS and provide patients with a survival benefit was submitted to the FDA
• Response from the FDA expected within 90 days
• Recent clinical trial failures by leading FDA approved drugs highlights the significant unmet global need for safe and effective drugs for the treatment of MND/ALS
• PharmAust remains on track to commence a pivotal registration Phase 2/3 Study for MND/ALS in H1 CY24
14 March 2024 – Perth, Australia: PharmAust Limited (ASX: PAA & PAAOA) (“PharmAust” or “the Company”),
a clinical-stage biotechnology company, is pleased to announce that it has filed supplementary clinical data from
its recently completed Phase 1 MEND Study with the United States (US) Food and Drug Administration (FDA)
Office of Orphan Products Development in support of its recent request for Orphan Drug Designation (ODD) for
monepantel (MPL) for the treatment of Motor Neurone Disease (MND) / Amyotrophic Lateral Sclerosis (ALS).
Best of Luck to all Invested ,,,
well worth another watch
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