Phase 2 recruitment should not be a major problem as they will likely be using the Healey Platform [Link below] which concentrates all the potential patients in the US in one place. I believe there will also be Australian patients.
10 Million was the cost suggested at the AGM but no firm costs have been announced at this stage. It is proposed to run an adaptive trial [Link below] these are suited to the Healey Platform and allow changes to be made at the any time, unlike the older more rigid methods used in the past. The trial will have a mid point [24 weeks] at which time the trial will can be stopped ether for extraordinary results or if its failing. Keep in mind the open label will still be running and those patients will have been on MPL for 2 years approximately. This has the potential to allow accelerated approval.
Method of paying for the P2/3 will be influenced by the results next month.
Keep in mind MPL could go straight into P2 trials now for additional Neurological diseases based on the P/2 MND trial.
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1017-7
https://www.massgeneral.org/neurology/als/research/platform-trial
Ann: FDA Grants PharmAust Pre-IND Meeting, page-36
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