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tootalljones

10/31/23 8:46 AM

#437651 RE: Hoskuld #437650

who writes: So far, Dr. Missling has successfully funding the company, built shareholder value, and seen every clinical trial succeed.
This is not supported by the facts. How has he successfully funded the company? Because its doors are not yet shut? How hard is it to dilute shareholders? The share price is the final arbiter, and the market, both of which prove that Anavex has gone from 30 bucks on a one day sugar high (it never deserved to ever be remotely that high) all the way back to $5.50, its current price, a failed share price of around an 80% decrease. The best one can say is that he has overseen this preciptous disaster drop but he also oversaw its climb as well.
So, the fact is, after 10 years, and programs still existant, we really don't know how any of this will turn out.
10 years is a very long time, but you will say hey, a decade at the helm is par for the course, etc....
The bloom is off the rose. Had you gone back ten years ago, when the share price was 5 bucks reverse split adjusted, and said the share price would appreciate 50 cents over the next 10 years, there would not be a single shareholder. Even instituitions which blindly throw money at this sector, would have sold.

And measured against true inflation of the last decade, or measured against thousands of other companies in the biotech sector or the market in general, whose share prices have soared, the company is a fail. A failure so far, and the market agrees. These are the facts, not rose colored glasses "facts."

To deny the endless broken promises, and the fact that the market does not buy the company as having made much progress at all (50 cents worth in an entire decade), is to ignore reality as so many LONG GONE shareholders who have lost precipitous sums, have commented. You haven't been around long in this stock, and are willing to forgive anything and everything.

Bottom line is the stock is not lower because of a liquified stock market, where money is everywhere still. The FED has said they were gonna drain the market but that has largely not taken place and in fact as rates have climbed the FED has simultaneously reliquified the market. If that liquidity leaves the market, and if AVXL has not provided the market with crystal clear data, the share price will go much much lower. If you like that investment proposition, @God Bless you. Facts are the facts. The precipitous decline the past 2.4 years in the share price is a fact. You don't get to make up the facts.
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LakeshoreLeo1953

10/31/23 9:07 AM

#437653 RE: Hoskuld #437650

Those "relatively frequent(ly)" meetings with the FDA must
have been less than slam dunkish as many insist is the destiny of
data/analysis discussed. Otherwise......
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Steady_T

10/31/23 2:48 PM

#437709 RE: Hoskuld #437650

As far as I can find there are no fees for meetings with the FDA. There are fees for filing an NDA which as far as we know Anavex has not yet done.
Even so the NDA filing fee is waved for an NDA for an orphan drug. 2-73 has orphan drug designation for Rett so no NDA filing fee.

FY 2023 and FY 2024 User Fee Rates
Fee Category Fee Rates for FY 2023 Fee Rates for FY 2024
Application
Requiring clinical data $3,242,026 $4,048,695
Not requiring clinical data $1,621,013 $2,024,348
Program $393,933 $416,734



Designated Orphan Drug or Indication:

An application for a prescription drug product that has been designated as a drug for a rare disease or condition under section 526 of the FD&C Act is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.