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crescentmotor

08/21/25 9:42 AM

#498590 RE: Doc328 #498588

If WS felt there was a 90% chance of approval, why would this stock not be valued at 10B or more at this time rather than sub 1B?



Because a substantial amount of players made a huge short bet early on that Blarcamesine will not be approved irrespective of the historical odds for EU approval after an MAA acceptance. Many of those shorts may cover their bet going into the binary event because a lot has changed since the initial clumsy roll out of the Phase 2b/III trial data.
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Hoskuld

08/21/25 9:47 AM

#498592 RE: Doc328 #498588

This is generally how life sciences investors make money: we understand the underlying value and probabilities more that investors. I haven't been wrong in 15 years - of course this could break that streak, but I trust regulators and professionals more than wall street. And, I am a real cynic - as you can probably tell: I don't believe anything but the data and the regulatory processes, so am not being polyannish about this. I thought that Anavex was insane not to run another confirmatory trial right away but...here we are. Apparently one undersized P3 and a small OLE are sufficient for the EMA to consider the application seriously - and the data and genetic subgroup analyses are compelling. I am still making money being cynical about this bet, but I am very biased to the upside.
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tschussmann1

08/21/25 9:56 AM

#498596 RE: Doc328 #498588

Fortunately, Wallstreet is not the entity that will be making the approval decision.
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Hoskuld

08/21/25 10:57 AM

#498606 RE: Doc328 #498588

Doc, an example of where Wall Street is very wrong, even after they have all the info and AFTER regulators approved a drug, is Verona Pharma. Last June, I think I am on record here as recommending VRNA (obviously many others also thought VRNA was a good idea, too) at $14 per share. This was AFTER Ohtuvayre was approved by the FDA. Now, it is $106 per share, 14 months later. By your method, Wall Street would have been right. But was it? Obviously, no. Arena Pharmaceuticals at $10...then $100 18 months later. The list goes on. I think you are trying to get other people to accept 1st order thinking: it is this particular price so that is what it is worth.

The wild valuations here are way off, of course, but the current share price is far to low to account for the potential - and often share price includes no value for potential. My expectation is that some of the vast potential will be realized. Will it be $100b or $1T in annual sales? No. But, it could be $2b-$10b...
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Investor2014

08/21/25 11:16 AM

#498612 RE: Doc328 #498588

If it really was as straightforward as any accepted MAA filing has >83% chance of approval it would be the golden egg laying opportunity to simply invest in all of those that looks to have a good return on approval. For some reason we don't see that reflected in stocks like $AVXL or $NWBO - what could possibly be wrong?
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MA52TA

08/21/25 11:25 AM

#498613 RE: Doc328 #498588

An easy question. Are institutional investors who INCREASE their stake in ANAVEX part of WS?
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sab63090

08/21/25 12:37 PM

#498631 RE: Doc328 #498588

Wall Street has no idea of the odds of a full approval or conditional approval, they only notice who has control currently and that has been the shorts...they will flip on a dime if given a reason to.
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boi568

08/21/25 1:28 PM

#498643 RE: Doc328 #498588

The way that investors make outsized returns is to be successful contrarians. Wall Street is not always right; it's right most of the time, but not always.

In this case, there is a clear disconnect between the EMA acceptance of the MAA and its subsequent approval stats and the high level of short interest in AVXL. I am keeping my eyes on the EMA, and not the hedge funds. The EMA gets to make this decision, and I don't believe, as you apparently do, that after due consideration the EMA foolishly chose to invest its time and resources into reviewing what is on its face a hopelessly doomed MAA. We know from their history that the EMA staff are much better than that.

There is a disconnect between the practice of other AD applicants running two large and comparatively lengthy Phase 3 trials and Anavex running just one smaller and shorter trial. Of course, the reason for spending all the resources needed for multiple large trials is not for its own sake, but instead to achieve statistical proofs of efficacy and demonstrate an appropriate level of safety. These were barely achieved (arguably) in the mab trials, but surpassed by Anavex in its single smaller and briefer trial. That is a signal of drug candidate strength, not weakness.

Or perhaps it's also because there is a general disbelief that this tiny biotech with its out of left field MOA can possibly succeed where all the big names have failed to produce a widely applicable, safe and easily administered AD drug. Perhaps those large investors and their advisors just preclude the thought that they have been so profoundly wrong about the science for so long and reject the thought that they will be proven wrong. This is a variation of the "not invented here" fallacy that usually occurs in commercial research labs, and it is a natural behavioral flaw among many scientists. In fact, after the amyloid approach has played out with minimal returns, a reasonable analyst should instead look toward other theories with an open mind.

There's a disconnect between the recent scientific research and the stock price that favors Anavex investors and is being ignored by Wall Street. This research is surely being considered by CHMP.

And, of course, there is a disconnect between CHMP's incentives and Wall Street's economic investments in mab technologies. This matters greatly in terms of predicting the odds of an EMA approval.

I am always encouraged by hearing the fallback argument of people on the other side who cite supporting economic behavior of others for the proposition that they must be right -- while ignoring the obvious reasons why they can all be wrong. It would be more convincing if they argued the science instead, but of course that argument wouldn't go as well for them.