PAA, A New Dawn , FDA ODD Approval and Entering Phase II MND Trial, page-85

I don’t believe they intend to use Healey, rather they will use Neals.

From my research it seems Healey is 100% designs for the USA (only) framework. It is not flexible because any drug joining the Healey Platform is just a regimen and it is plug and play. If the requirements for MPL approval in EU and AU are not covered in the Healey framework, too bad. My understanding is that it may not be suitable.

Neals on the other hand can be designed and run to the precise requirements to cover all locations regulatory needs.

so from the presentation yesterday, looks like the company is parking up Healey and going with Neals consortium. They are equally amazing!

one other thing I have been uncovering is that while Healey has some cost profile efficiencies, they are maybe not material and that is without having to pay to cover regulatory gaps for USA patients to be utilised for EU and AU approvals