Barriers and Persistence

Last week, the Michael J. Fox Foundation informed us that our second grant application to support the proposed Phase 2A clinical trial was not selected for funding.

Given the Foundation's encouragement to reapply after our initial submission, the news was difficult to receive. We had reason to believe they recognized the promise of our program and its potential to transform the care and lives of those living with Parkinson’s disease.

To the Foundation's credit, our second application was reviewed by three outside experts with diverse backgrounds spanning regulatory affairs, clinical trial design, and translational research. Unfortunately, major recommendations from the reviewers were similar in nature to the those from our first submission. Questions were asked where answers were included in the materials submitted. Requirements were listed that did not align with FDA feedback during our pre-IND engagement or in the Federal regulations. I understand the demands of serving as a scientific reviewer - especially in this case where the proposal runs counter to all the standard teaching and standard practices.

But scientific breakthroughs rarely come from repeating the same ideas. Some of history’s most important discoveries — from hand-washing to the small pox vaccine, from radioactivity to penicillin — were born of curiosity, persistence and the willingness to take a chance on the unexpected. I recognize the challenge of balancing innovation against the imperative to protect human life. For people with Parkinson's, we must also act with urgency to identify new therapies considering the shortcomings of those born from studies in the 1960s.

Our team’s persistence and commitment to bold, evidence-driven scientific investigation remain unwavering. Without pushing the boundaries progress will not happen. As I said in the Movers & Shakers podcast, accepting the status quo is accepting defeat.

This is a setback; not a hard stop. We have an alternate strategy and are moving forward. We remain committed to advancing this work.

Stay tuned!