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Thursday, July 18, 2019 7:58:09 PM
There has been a bit of discussion as to what dosages the P2a subjects are currently on and when they changed dosages, if they did.
Given that the subsequent data has always been reported in terms of blood concentration, we still don't know the details.
When we combine the known genetic make up which responds to our drug with the gut make up which corresponds to the drug, we can use this in ph2b trials and extensions now and verify results. When we enroll ph3, we will need fewer patients because every one, EVERY SINGLE ONE, except placebo recipients, will respond and meet endpoints with flying colors. We could achieve a near 100% response rate. That is a fact. And it has been suggested or written or stated, that we fully intend to stack the ph3 trial. (I think I recall Investor posting the reference, if incorrect, I apologize.)
You are assuming that gut make up is the controlling variable. We don't know that at all. It could be many other things, like liver function or many other possibilities. Given the variability in the IV administered drug resulting blood concentration levels the gut may not be involved at all.
What we do know is that the wild type genome folks appear to respond better as a group than those that have the mutated genes. That hypothesis is currently being tested in the current P2/3 trial. Until that data is in and analyzed we don't know if that hypothesis is a statistical fluke or does in fact exist.
The gut diversity data that we have been shown indicates that there is a correlation between gut bacteria diversity and AD progression. What we don't know is what the gut diversity of the subjects was when the trial started. For all we KNOW that diversity difference has been there since day one.
I don't like sounding like a killjoy. I do like understanding the limits of the data. It is easy to over interpret that data when you have a vested interest.
Noble prize winner Richard Feynman said "The first principle is that you must not fool yourself and you are the easiest person to fool."
That applies here.
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