Living "why not Wednesday?"
I planned to reconnect after January 1st, but yesterday - on Wednesday - I lived "why not Wednesday" - a theme of this newsletter.
We've been working hard to complete the manufacturing of the three doses of RB-190 (and matched placebos). And because of our terrific chemistry and manufacturing team, we should be done making thousands of these wonderful tablets this month. That means that by the end of January we'll have test results back that we need to apply for permission to launch the clinical trial. Very exciting to be at this point - though as I've said before - it's taken so much more time than I expected.
In parallel, we're learning how lucky we were to be introduced to the leadership of the Australian Parkinson's Mission. It would have been a lot if they were just kind, thoughtful people. It would have been a lot if they were just brilliant. It would have been a lot if ... (see the pattern here?) they were just so enthusiastic about the trial testing RB-190. They are all of these things.
And the process is underway to qualify for and then to form a subsidiary in Australia, necessary to conduct the trial.
All this means that we are ready to propose a better program to investors. And ready to resubmit a better grant proposal to the Michael J. Fox Foundation.
But there was a catch. A seemingly small administrative problem meant we would not be eligible to apply by the December 11th deadline and instead would wait another couple of months. Delay, delay, delay. We need to make faster progress!
My colleague Keith and I shared our disappointment, until he said, why not just ask the Foundation to look at our situation an consider letting us submit now? Yes I am the optimist, but I did not really take the suggestion seriously. He insisted. He sent an email. The Foundation responded that they would allow us to submit today. And because we were preparing for this target, we could pull it off. This morning at 4:16 am I uploaded the last file. I laid down for a couple of hours and then signed back on to see several errors I had made in formatting etc. I fixed them and our proposal was successfully submitted!
There's no way to know what the Foundation will decide, but we'll know soon (end of March). And Keith taught me a lesson - don't abandon the mission!
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About Jonathan Sackner-Bernstein, MD
Dr. Sackner-Bernstein shares his pursuit of conquering Parkinson's, using expertise developed as Columbia University faculty, FDA senior official, DARPA insider and witness to the toll of PD.
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RightBrainBio, Inc. was incorporated in 2022 to develop tranformative therapies for people with Parkinson's.