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abew4me

05/29/20 6:50 PM

#252939 RE: Doc328 #252938

Thanks doc. Your inside knowledge & experience is greatly appreciated!
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Biostockclub

05/29/20 7:15 PM

#252941 RE: Doc328 #252938

Doc -

Appreciate your input.

Here’s a thought:

Instead of fretting about the mere possibility of many bottles floating around older persons’ houses (up to 9 bottles), and conjecturing poor eyesight - I mean that’s all possible but we have to fictionalize that to get to a destination that this is a bad idea - and isn’t that what bias is all about - not trying to make the narrative fit the outcome, but having the outcome flow from the narrative?

I submit the following solution to the many different doses being confusing conundrum: (I won’t invent a young caretaker with keen eyesight to embellish unknown facts...)

How about a rep from the CRO gives or mails each participant a month’s worth of plastic pill holders or zip lock bags (small) containing 3 pills? Each bag can be premeasured to the exact dose - just eat the 3 pills in each bag each day. That can’t be too difficult can it?

So, there’s a workaround for everything, imo. A little ingenuity goes a long way.

Appreciate your input and we should humbly accept what we don’t know and react according to that information or lack of information - it really is called “faith” because we don’t know why things are not being disclosed in the manner in which we are accustomed in prior trials.

We can’t control what Missling designs. We can’t know if it will work out better or worse or the same as all other trials. We can only control how we feel about our not knowing. If we feel strongly that something is amiss - no guns to our heads saying we must invest.

If we feel he has a handle on things, ride it out.

If we try to gain an advantage by attempting to know his exact move and determine if we agree with it in principle, we still are taking a chance on failure or success, albeit, a more informed one. But, he isn’t going to accommodate our curiosity at this point - so it’s faith to act or not to act (the Hamlet dilemma) in support of this company with our dollars.

I will state that Frrol has me convinced that this is a deliberate action taking place since it spans all indications and locations. This is not a random error. It implies a strategy - whether good or bad...
here is you quote which applies:

“ However, without wasting time looking at hundreds of studies, I can't say leaving the dose out is unique.”

We are all in that same boat.

Thanks for your time and input - added value to a discussion which remains speculation unless a resolution is provided - even after results, these dose details may never be resolved - but they will not matter (whether older folks uncapped 9 bottles or simply took prebagged contents will be insignificant) only results will be approved not the method of administering. I can take my pills at home any way I want - break them in half, chew, swallow, space them out or all at once - whatever. If they work that’s all that matters (discounting nitro tablets or emergency meds: rescue inhalers and such, and neglecting grapefruit juice or food/empty stomach instructions...you get the idea).

Thanks for weighing in.
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F1ash

05/29/20 7:40 PM

#252943 RE: Doc328 #252938

Just a note but they are apparently capsules not tablets.

Drug: High dose ANAVEX2-73
Active oral capsule


https://clinicaltrials.gov/ct2/show/NCT03774459?term=Anavex&draw=2&rank=4

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frrol

05/29/20 8:11 PM

#252944 RE: Doc328 #252938

Thanks. As for Anavex's dosing opacity, it is just something that will go unexplained. I'm also pleased to hear from alternate channels that it's 30 and 50. When plasma concentration is such a tricky factor, it's good to hear our MTD is intact.

After efficacy signal, I'm rooting for clearer dose effect in these trials. They're bigger n, so there's hope. If we don't get it, then hopefully there's some (other) correlative to plasma concentration clearly identified.