Logically analyzing the publication(?), ASM note, AD trial together with some DD.
A lot of discussion from brichnyc ASM notes particularly about the publication note:
"Major publication will publish data from the Phase 2A trail instead of presenting it at a scientific conf."
But look at his note just before that...
"Will look at data next at 208 week mark for the original patients"
That seems like a major clue that the published data MAY include all the data up through week 208!!
So the doctor is sidestepping the placebo issue and going to publish this Phase 2A AD data...WHY?? Thats crazy, Pharma will yell PLACEBO!!??
Because he has GROUNDBREAKING VERY GOOD data indicating great improvement!!!
So what is this data showing NOW, that would cause Anavex to go out on this limb?? How can we find out?
Lets look at the recent corporate presentations. They show what Anavex is telling potential investors, so it should be the latest and greatest POSITIVE news!
In particular lets look at the AD positive scientific DATA, as this is the science. This is the type of data that will be PUBLISHED!
There is a slide showing higher concentration shows more improvement than lower...OK. This is not suprising for a drug that WORKS.
The heart of the science data is..
1) The nice data slides indicating improved activities of daily living (ADCS ADL) scores and MMSE scores (citing Hampel), showing data out to 57 weeks.
This is accepted, reproduceable tests. Imagine this data updated and plotted to publication time!
2) There are two nice data slides that test AD patients speed (milliseconds) in identifying a red versus a black card. These tests the patients cognition and reflexes and are the AIBL-ROCS and Cogstate IDN tests.
This is hard, reproduceable data, showing patient improvement in coginition and reflexes. These are very interesting slides as they show A2-73 patients demonstrably improving. But these plots only go to 17 weeks and only have two A-2-73 data points.
It appears that in the first five weeks A2-73 patients response improves about 68ms, and maybe 90ms at 17 weeks. But with only two data points, there is not much info, but it appears that over time the patients continue to improve.
It is frustrating that these slides only go to 17 weeks. Who knows how much improvement there is at 52 wks, 148wks or publication time??!
Note that these slides cite YY Lim in the journal Clinical Neuropsychology. Might this be where the Anavex data will be published?
Now lets look at the endpoints of the current AD trial, for hints of what data is being collected and looked at.
1. Primary outcome-> ADAS-Cog.(AD Assessment Scale) Bingo! Adas-cog are COGNITION tests which correspond to MMSE (www.ncbi.nlm.nih.gov/pubmed/26617181) tests. Also we listed cognition tests in 2) above!
2. Primary outcome-> ADCS-ADL (Activities of Daily Living). Bingo! As we listed in 1) above!
Other slides cover autophagy, Sigma-1, and cell homeostatis. The published article will probably tie all this CAUSAL science together with the data, so that the scientific community, and hopefully the public, respond with "OH. I get it. There is a great story here!"
I have tried to stick with the facts and not get to far off into speculation land. It helped me tie a lot of loose ends together. I hope it helps someone else!
