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Re: Steady_T post# 100429

Tuesday, 09/30/2014 11:23:28 PM

Tuesday, September 30, 2014 11:23:28 PM

Post# of 146301
All Toxicity and Safety testing for regulatory submission require assessment in various tissues including the central nervous system (CNS).

The 10K filing covered that there is ongoing development to monitor the levels of Flucide drug throughout the body during PK studies of ADME.

I think the clearance rates will be more important than the partitioning (or lack of it) into various tissues and end organs - including the brain. If it clears from the brain and elsewhere with typical kinetics in reasonable times (non detectable at ~3 to 4 weeks), then it should not be a problem. If it remains partitioned in the brain for longer periods, then maybe there will be more of an issue.

So will the physical mechanics dominate (particulate micelles distributing evenly and clearing through glomerular filtration through the kidneys)?

Or will chemical interactions dominate (sialic acid mimic ligands partitioning more toward areas of higher sialic acid concentrations such as the brain)?

I do not know and neither does the company until they can develop the analytical detection methods to monitor FluCide in the various tissues and run the animal studies.
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