Ann: FDA Provides Clear Feedback for ODD Approval, page-143

Hi Aboo

Wish I could deliver you some certainty.....

BUT what I can do is show you Risk Reduction

The DSMB monitored every Patient Cohort vigorously , especially as the Trial had a component of escalating doses.

Each Cohort was screened and NO SERIOUS ADVERSE EFFECTS recognised, this allowed that Cohort to then move forward on the next increased dose.
( I have seen trials cancelled mid flight by the DSMB for) " No Patient Benefit" ethics does not allow Human Trials that do not demonstrate "Patient Benefit"

PAA are fortunate to have Mathers and Rowe as our Principal Investigators , "They see 40% of all MND Patients in Australia"

All of the Trial Patients have outlived the Disease ,Some significantly as they were diagnosed well before the trial commenced.

The DSMB and Medical Advisory Board have allowed all Patients to remain on MPL,,, This is a NON Proven , NON FDA Approved Drug that is one of the worlds first "In Human Trial" certainly a first for the Newly Formulated Refined and Micronised PAA Tablets.
Rowe and Mathers would be party to this occurring and with deep institutional knowledge ,understand the ramifications and consequences of such a recommendation. " Arse on line" comes to mind.

All Patients have "wanted" to stay on the drug.

All of the Patients are Breathing, Swallowing and Speaking ,,, "from watching MND Patients , surely not being able to speak would be terrifying and brutal"

The easiest answer to give is "NO" and as the data analysis is ongoing as we speak "You can take solace that the current answer is Yes, the second the data shows failure then further analysis is redundant"

What many have not calculated is that the Phase I/II results deliver far more that just MND Data , It demonstrates that PAA MPL Tablets are safe to take.
It Demonstrates that a beneficial dose of MPL can be delivered across the Blood Brain Barrier utilising the mTOR Pathway... and that Aboo is why Big Pharma will want a slice ,, someone the size of Pfizer could fast-track Cancer , Covid Trials and Hold FDA Vouchers to put them at the top of the stack.

Hope that helps you get some sleep,,, I'm excited , Great Results V8 , Spectacular Results V12 with 2 coats of blue unobtanium please..