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News Focus
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abew4me

12/16/21 12:50 PM

#340224 RE: boi568 #340218

Great post.

It gives a more comprehensive view of how and why we have delays.

Thanks
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Jonjones325

12/16/21 12:58 PM

#340226 RE: boi568 #340218

Agreed. All of our upcoming trials are dependent on the incoming information. Like so many have said, the new knowledge and data gleaned from the Rett and PDD OLE will help to confirm and/or tweak.

I still believe we will get a PDD surprise. Missling wants to get it right without any shoulda, coulda, wouldas.

So much going on behind the scenes. It's difficult to appreciate since we all wanted the results yesterday.

When is does come and decisions are made, I know it won't be sloppy.

PDD BTD coming to a PR near you!
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frrol

12/16/21 1:00 PM

#340227 RE: boi568 #340218

You wrote: "Missling is not willing to release data with anything left unexplored." In every clinical trial so far he's released TLD and then followed with further data releases. So no, unless you spoke with him and he said he's changed his mind in last couple weeks and told you he is now not releasing TLD but waiting for full results instead. And then you'll still have to explain how an extra month buys "not leaving anything unexplored". That's how quick it is?

We're getting Avatar's top line results, they'll likely be around YE 2021, and the same is true for the 3-71 Phase 1. There's no full-results-because-it's-so-awesome fantasy going on.

Keep eyes out for that press release. It's exciting!
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end2war

12/16/21 1:30 PM

#340231 RE: boi568 #340218

boi568

I agree he is detail orientated and thorough, good qualities for someone trying to solve a scientific problem. I too have noticed his evolution of thought.

It would be very interesting to spend a night with Missling talking about how his thinking evolved since he first became in charge of AVXL. It seems amazing to me that they had A2-73 so early before they really knew what it could do. I am anxiously waiting to find out what new, and persumably, improved qualities inhere in 3-71, which appears to be the result of a decade of thinking about SR1 and its muscarine co-receptor.
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powerwalker

12/16/21 2:20 PM

#340243 RE: boi568 #340218

boi, been in your camp on that reasoning for awhile.

Question for you and/or others: If Anavex had all the data + analysis and were discussing next steps with fda, does it have to disclose the former? Or, is it able to defer until course of action had been agreed with the agency? As such, Anavex and TGD are waiting for a decision from/additional discussions with the fda as to how Anavex should proceed

Purpose to not disclose is to minimize competitors' efforts to provide blow back on the Anavex data and/or influence the fda.

TIA

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