- PharmAust (ASX:PAA) is collaborating with renowned clinical study design expert, Berry Consultants, to design and analyse its planned phase 2/3 study for monepantel in patients with MND and ALS
- Dr Melanie Quintana from Berry Consultants will lead the statistical analysis
- Berry Consultants actively manages the largest ALS study to date
- Recently, PharmAust secured approval for a Pre-IND meeting from the United States FDA
- PAA shares last traded at 13.5 cents
PharmAust (ASX:PAA) is collaborating with renowned clinical study design expert, Berry Consultants, to design and analyse its planned phase 2/3 study for monepantel in patients with MND and ALS.
Dr Melanie Quintana, an expert Director and Senior Statistical Scientist at Berry Consultants, will lead the statistical analysis.
“We are delighted to be working with Berry Consultants as their reputation and experience in designing and conducting the statistical analysis of MND/ALS studies is unmatched.” PharmAust CEO Dr Michael Thurn said.
Berry Consultants has partnered with the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, actively managing the largest ALS study to date.
Recently, PharmAust secured approval for a pre-investigational new drug meeting from the United States Food and Drug Administration (FDA).
The primary agenda of the meeting was to gain crucial feedback and guidance on the adaptive phase 2/3 study’s design.
Berry Consultants will play a pivotal role in shaping the study’s design, strategically positioning monepantel for FDA approval in the treatment of MND and ALS.
PAA shares last traded at 13.5 cents.