After re-listening to the recent conf call, I'll try to summarize what we know (or think we know) -
1) The "finding" is a STRUCTURAL change/changes in the cells of the target organ, and is visible under microscopic examination of the target organ after the animal is sacrificed.
2) The finding can be reliably reproduced in the test animals, not in just a small minority of the animals. So it's apparently not related to a few unhealthy animals having an existing, underlying disease state or metabolic abnomality.
3) The finding is dose dependent - it is only seen in animals that have been dosed at very high doses. At low dose levels there is no finding.
4) Once past the first 2 weeks of dosing, the finding is not dose duration dependent. The finding looks exactly the same microscopically after week 2 as it does after week 13 (ie - it doesn't seem to get worse over time).
5) When the target organ is immediately removed and frozen after the animal is sacrificed, the finding is not seen.
6) The finding is only seen when the target organ is prepared in the normal slower fashion, and fixed with the usual chemical fixatives.
7) The finding is NOT seen with other Ampakine compounds, even when the target organ is prepared in the normal slower fashion, and fixed with the usual chemical fixatives.
8) There are no apparent clinical manifestations associated with the finding.
There are several key variables here -
a) The length of time between the sacrificing of the animal and the removal/preparation of the organ, and
b) The use or non-use of chemical fixatives.
Summarizing - slow with chemicals produces the finding, while fast without chemicals produces no finding. To determine if the critical element is the time factor or the presence of chemicals, one should ideally get data for all 4 possibilities - slow with chemicals, slow without, fast with chemicals, fast without.
Well, I just ran out of my 15 free daily I-HUB posts for today (thank goodness..:o)
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