@ma420 mate, great summary, you got it right. ✅
If everything comes together time-wise with enrolments and placebo share-group allocations and trial designs and new regimen inclusions - it is possible for a mid-2025 interim readout but the wise heads drinking beers and wines after the webinar concluded it's not likely till later in 2025.
Another aspect from the Sydney sessions, that came together with much deeper appreciation ...
Patient Outcomes + commercialisation of MPL
@JakjazzIt is worth repeating, for obvious reasons, that slide you mentioned, as it points to just one of MT’s special focus areas, that highlights the importance of ALS patient care and empathy, as drivers for PAA’s community awareness and focus on patient outcomes, and for corporate governance responsibilities, and not just items for financial value-added propositions.
PAA have taken the time to showcase what it will mean for existing ALS/MND survivors, and for future trial participants in the Healey platform, where their one clear and undivided primary focus is on holistic patient outcomes.
“We are thrilled to work with PharmAust leadership to design their regimen to investigate Monepantel for people with ALS” said Merit Cudkowicz, M.D., M.S.c.,
principal investigator and sponsor of the HEALEY ALS Platform Trial, director of the Sean M. Healey & AMG Center for ALS, chair of the Department of Neurology at MGH, and the Julieanne Dorn Professor of Neurology at Harvard Medical School.
“We are grateful for the continued support of our industry partners, research collaborators, clinical trial sites, and the contributions made by our patients and their families” said Sabrina Paganoni, MD, PhD,
co-principal investigator of the trial, physician scientist at the Healey & AMG Center, Co-Director of the Neurological Clinical Research Institute (NCRI) at MGH and Associate Professor at Harvard Medical School,
and member of PharmAust’s Scientific Advisory Board “dream team” includes internationally-renowned experts in MND/ALS drug discovery and clinical development who will provide PharmAust with strategic guidance in the development of MPL.
And I’ve listed out those comments, as Merit Cudkowicz & Sabrina Paganoni will be representing PAA to the US ALS community,
and showcasing PAA’s materials to potential trial participants, their families, care-givers and physicians.
PAA will be working closely with the Healey & AMG Center ALS Trial Design Team, Northeast ALS Consortium (NEALS) and Berry Consultants to tailor the arm of the Platform Trial to Monepantel and work together going forwards on ALS therapy development.
And I emphasise all these comments, to pull the threads together and drive home that this outcome is just one part of MT’s precise and strategic focus from early on in his 10-month tenure when he identified the Healey Platform as providing the highest possible achievement outcome for a clinical trial evaluation, providing invaluable exposure within the ALS research community, providing the most cost-effective and efficient timelines, accelerating progress towards delivering a much-needed therapy for patients with ALS, and guiding the fastest track for commercialisation of MPL.
From day 1, MT was all about:
Patient Outcomes + commercialisation of MPL
That was the start point for the commercial outcomes listed above. The global exposure is our new target market, and the Healey Platform trial outcomes will provide global relief for the PALS community.
Also, if it is not enough to be globally recognised as a leading contributor in ALS therapy development, the Healey Platform will also benefit from assessing, designing, and leading a successful and viable treatment for ALS.That’s their core business and motivational driver for their individual and collective research, development, clinical and statistical work.
This is a collaboration with extremely important outcomes for everyone concerned.
cheers,
Ice
(20min delay)