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ohsaycanyousee82

09/21/25 8:41 PM

#501263 RE: powerwalker #501261

I got news for you. He ain’t goin anywhere.
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Investor2014

09/22/25 3:29 AM

#501271 RE: powerwalker #501261

Well I am wondering on what basis some can hold onto the idea there will be no CS2?

you are working so HARD to convince people there will be a CS2


Given that when we see “Scope: List of Outstanding Issues / Action: For adoption” in the CHMP highlights, it invariably that means Clock Stop 2 has been triggered. It is what happens in the majority of CHMP evaluations.

Time will tell and we are still in with a good chance, but not 100% certain.

For the record once again my bet is on CMA with a confirmatory trial. I most certainly don't wish for a rejection or withdrawal PW!

If we get full approval that would obviously be wonderful - wonderfulness is just not a concept that fits my biotech investment strategy and experience.
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Hoskuld

09/22/25 6:58 AM

#501272 RE: powerwalker #501261

It is probably true, but also generally not a bad thing either. And probably true doesn't = true...so we wait.

The MAA has come so far, seemingly without incident. We just have to wait 50 days now to get the CHMP verdict. In the meantime...is it really possible to change anyone's mind? If you are long, are you going to sell between now at Nov 10th? If you are short, are you going to cover before Nov 10th? I haven't seen a lot of movement on this board over the last three years, so positions are probably pretty hardened.
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LakeshoreLeo1953

09/22/25 10:12 AM

#501283 RE: powerwalker #501261

How is it that the idea that CS2 is in effect a disaster for certain people?
It is the NORMAL procedural point in the EMA MAA approval process.
IF the WGT crowd wants to put a number out there for approval, the
probability that Anavex IS IN CS2 is higher.
The same attitude is quizzical when outright approval has morphed into
whether a P3 is really a P4 and is of no consequence to the faithful.
The missteps of Missling over 10+ years are numerous, but this CS2 is not one.
An inability to be prepared for and straightforward in response to the LoOI is crucial.

Chill folks. Make sure your dry powder bunker is leak proof.
IF the Holidays finally deliver that shiny bicycle some cite, will $10 buys really matter?
I am tired, however of trying to catch falling knives
Reminds me of the culture shock first time visiting Petworth Cigars in DC.
A normal $20 stick was $40, but I got to watch the people walk by.

This MB is about as polarized as the Genpub so seemingly the vitriol is not unusual.
I still say 40% here will be silent when CHMP speaks and EMA answers.
A few will just chalk it up to process and performance.
The Market WILL fill in that scorecard.

In the short term....I trust Anavex will not find it necessary to ask for an extension in 26 days.