Progress

We’re making terrific progress as we prepare our application to conduct our first trial in Australia. The protocol and informed consent forms are complete. We are preparing the documentation of the drug manufacturing process and its quality testing. The summaries of both nonclinical and clinical data are in final edit for the Investigator’s Brochure. You may not know what these individual components are. Think of it this way: we are close to being ready to submit.

In parallel we have additional processes moving forward. These include:

• We are contracting with a firm that is expert in reviewing and submitting the clinical trial application to the Australian review committee with the official notification to the government, which should provide feedback within 4-6 weeks.
• We are preparing to ship the drug (and placebo) from the manufacturer in India to a specialty firm in Australia where it will undergo labeling to be compliant with Australian requirements.
• We are building the data collection forms and database necessary to capture data electronically in the clinical trial.

In parallel, we continue to pitch for the remaining funds we need for the trial (we are getting closer to our goal).

I was reflecting last night on the progress we’ve made since starting on this mission in late 2017. It feels remarkable. We discovered how the disease progresses, identified a drug that is now shown in 9 models of disease to reverse pathology, secured patents in the US and EU, secured a manufacturer (which has processes/systems nailed down to synthesize the chemical and turn it into tablets), defined how to make those tablets so they deliver the drug reliably, established a relationship with a world-class group of clinical trialists in Australia and figured out how to run this first clinical trial to demonstrate that we are right – that Parkinson’s is not a disease of dopamine deficiency – which puts us in position to prove that our drug conquers the disease.

Notice I’m skipping the experiences of being told “no” and being dismissed because that is part of the journey when upending the standard approach.

I was reflecting on how far we’ve come while somewhat mindlessly scrolling through LinkedIn feeds. And then an image appeared – admittedly hard to see with the small type size – that helped me see how far we’ve come.

We’ve tackled discovery and development while setting up operations and regulatory in consideration of the impact on the lives of those affected by Parkinson’s. And we’ve done it while staying focused on commercial and post-market needs – since we need to do that if we expect to get the additional investments needed to get past Phase 2.

I appreciate the engagement and feedback from those reading this blog, watching the on-line videos and listening to the podcast appearances. And I am proud to be surrounded by the team of experts who are making all this happen.