Shareholder Meeting – Part 2
Please note. I am only including facts and what he said. I will share my opinion later.
Alzheimer's
-The Alzheimer’s 2a trial was intentionally complicated to learn as much as possible.
-Sample size is more than sufficient and gives us the signal to move forward. He said that in some oncology studies, trials were planned using a signal in as few as THREE patients, which eventually led to approval. So, in comparison, we have more than enough and the signal we have is strong.
-Safety was emphasized. Since the MTD was shown to have some adverse effects, they will use a lower dose. Smart.
-Extension for our current patients will be forth coming if they opt to continue.
-He acknowledged the fact that MMSE and ADL are not precise measures due to their somewhat subjective nature but it does give us a signal that something is happening.
-Genomic signature found and to be reported at an upcoming conference. The signature allows them to accurately predict who will benefit most from 2-73. This way the data can be used in all future trials.
-Missling believes that our drug would have been proven to work regardless of which type of trial is done. Even if we didn’t have the Ariana or Illumina data. Now that we have it, it gives us an even bigger advantage and significantly increases our chances of success.
-Illumina was not in the plan all along. After he saw the failures that were occurring last fall, he decided to take a step back because he did not want to go down the same road. Hence the delay and hiring of Illumina.
-He said the delay and the hiring of Illumina was a wise decision and he was very confident in the signature(s) that was/were found.
-Alz IND still on track to be submitted this year.
-They will NOT wait for the Rett read-out before starting the Alzheimer’s trial. There’s no need to. They are completely different indications and the info learned will not really effect the Alzheimer’s study. They are completely independent.
-He was not sure as to the main reasons why our Sigma 1 agonist is superior to the others out there. He said the muscarinic may have something to do with it. He also said there is a difference between Sigma 1 activity and Sigma 1 activation. We have activation and the others have activity.
