The view from the battlefield:
Parkinson’s Disease alone (PD) is classified as a physical disease and affects mostly motor/speech skills via impaired motor neurons.
Parkinson’s Disease Dementia (PDD) is classified as a mental illness, dementia, brought on by PD and affects/impairs cognition, memory, learning, thoughts, orientation, and normal mentating function via the brain neurons.
Our PDD trial Ph2 in Spain and AU of 150 participants was for the indication PDD. The trial was labeled as such and designed with dementia/ cognition tests as primary endpoints. This was at the suggestion of the MJFF who partially funded the research.
Originally, the trial which Anavex wished to conduct was for PD based on very strong signals in preclinical mouse models with PD in which motor skills responded to the drug very favorably.
The PDD trial focused on dementia as primary endpoints and made motor skills secondary endpoints due to:
The early favorable signal from the Alzheimer’s ph2a study on 32 patients in Australia.
Also, the unmet need in PDD - no drugs which are being used to treat due to inefficacy.
So, I’m essence, the 2 different components were merged and we got cognition and motor for the price and time of one trial but took a big risk if either component were to fail.
On August 5th, the TGA in AU granted SAS for the drug treating the early AD patients. (Strictly a cognitive condition)
Today, the Australian arm of the MJFF announces partnering with us to back a longer trial strictly for the motor portion of PD.
The results of the PDD 2a trial are due out by end of Sept. according to Dr M on cc.
All entities (TGA and Shake it Up) could have waited for results before granting SAS (for AD - cognition) and 50% stake in PD trials for motor skills.
Neither one did.
According to Anders, one of our many legal posters, Anavex has 5 days to report failed trial results - material. Conversely, if results are good, even though material, the company can slow roll the results announcement without being in jeopardy of breaching material info disclosure because there is no damage incurred to investors. I’ll add, if the results are being used to secure even more favorable deals for the company and status for its compound, shareholders have received a benefit as opposed to damage.
If the TGA granted a cognitively impaired group of people (original AD group and others like them) access to a drug which based on results of an actual trial (PDD) using the very signal from those original AD participants, the conclusion is that when the results are announced, shortly after, the TGA looks good for granting a successful drug special access scheme status.
Likewise, if Shake it Up partners with us to back half of the trial costs for a drug which announces the following week or two weeks that the secondary endpoints of the PDD trial (which were PD motor skills) were passed with flying colors, they look good and are not providing their members false hope; just the opposite - compassionate use case will be pleaded loud and long.
And, if Dr Missling said the results of PDD will be announced before end of September, the only way he could know that for sure is if he knew that was accomplishable or accomplished when he said it. He didn’t have to release data if positive until the deals were in place but he was obligated to announce failure.
No announcement of failed results has been made.
Deals were.
Expect positive results. Primary and secondary.
Thanks Anders (sorry to use your remarks without permission - I owe you!).
And, finally, let me reiterate what was told to each and every one of us at the beginning of 2020 by Anavex:
2020 is the Year of Execution
- all of the planning took years, the execution is well underway based on that planning / so don’t be surprised by anything we see go into effect this year, and we all know what follows execution phase...
The big payoff for patients, science, investors. I expect with each new set of results and agreements and knowledge gained this will be the longest running phase of the company.
It took years to plan the Apollo 11 space mission (rocket scientists, engineers, etc), from liftoff to splashdown took 8 days, the knowledge gained is still being used and built upon 5 decades later.
Let’s watch people get well and keep those dividends rolling in for decades after execution!
Best to all on board,
Biostock
