Nidan,
I interpreted the patent in the same way that Lima/Investor/Xena did. This was a dosing regimen alteration based on the original 2a Australian safety phase patients.
I think this regimen is to heighten our drug’s response for those who remained outside the strong responder group.
Lima’s suggestions about our dosing in that trial and the benefits is spot on.
Xena also posted similar case for the switching on and off dosing and provided the gut biome slide stating this is continuing.
Aside from the fact that I can’t find a correlation between the gut biome and the gender discrepancy in AD prevalence, I think we are on the same page - switching on and off accounts for something. I included the gender bias and went with the sex hormones to account for the effect.
Investor also pointed out exactly what my DD showed: the binding affinity of DZP is stronger but, yes, of course, it occupies the receptor for a much shorter duration of time, thus allowing for 2-73 to get in and agonize linger. More importantly, the metabolite remains in the receptor agonizing for longer duration and extends the effect. Therefore, I agree that DZP does not interfere with our drug in the very mild dose it is combined in. If anything, DZP could exert its shorter agonizing effect along with 2-73 and the metabolite to restore cellular balance even more quickly, which would reintroduce the sex hormones, once cortisol overproduction drops off.
That is, unless the S1r is blocked from a potent inhibitor such as progesterone. Thus, the need for a wash out period.
This could explain why DZP, when used alone, stops working after 6 months or so. Perhaps restoration begins and improvement reaches a point where the cortisol drops off allowing the progesterone to be produced and shut out the drug from then on. No further effect can take place. This holds water in theory. It’s possible Anavex noted the problem and attempted to fix it by stopping agonism long enough for the cortisol to take over again but not long enough to cause deepened impairment or further Amyloid buildup. This looks like a balancing act of keeping the cells under enough of a mild stress state to prioritize cortisol production, then, when that drops off as homeostasis is recognized by the body’s sensors, switch off the remedy, long enough to put it back into a mild stress state. The device could help monitor those levels easily.
Some larger picture items:
End of stealth management?
Look no farther than the origin of this “new” information. Did not come from management. Came from a board poster...ever watch Stalag 17? Just sayin’
This info was very benevolently “pointed out” enthusiastically at this point in time. Watch yourself. As Zig alluded to, there is precedent for this being done in the past. Proceed with extreme caution. Land mines remain unmarked for a reason.
As to the patent being in Cecchi’s name:
If you look at the timeframe, I think the IP picture at the time this was introduced was not as strong as it has become. Also, we had the MTA with Biogen around that time, and no poison pill in place. I suggested that if we were the target of a hostile takeover, they acquirer would get everything including our platform. I recommended that Anavex divest all of our compounds to Abraham Fisher, put them in his name or sell to him, so that if the company were acquired under hostility, we would protect those assets and begin anew.
Perhaps, that was similar thinking about the dosing regimen patent: we may have known that A2-73 given continuously would restore homeostasis but the effect would taper off just as with DZP unless the drug were washed out intermittently. If so, makes all the sense in the world to put that patent in another name for protection - so that the acquiring entity would have a useful compound for only a short duration. Then, we would be able to achieve SOC be introducing a more effective dosing regimen. That’s not crazy thinking - that was strategically correct.
Now that we have the poison pill in place, the patent can be transferred as it is not inalienable to the inventor and can be transferred to another name or entity.
Finally, this furthers the notion that we have not registered the trial in Australia yet because...we are waiting for IP approval in order to use the protected intermittent dosing regimen and the results (not publicly disclosed whatsoever!) as an extension which will be approved following the PDD approval - BANG BANG PLAY.
If this is what is taking place - genius is at work once again (and has been in place for some time), but again recall why did we get this information at this time and the source?
(Watch Absence of Malice to learn about pawns and set ups.)
BR,
Bio (please pardon typos)
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