Anavex Life Sciences Corp (AVXL)

[F1ash]

Your questions are deteriorating into the realm of the nonsensical

It was a rhetorical question. If you follow the thread backwards you might see why I asked the question, even though the answer was obvious.

Now that I have a bit more time...

Let’s start with some disclaimers. I do not now, nor do I remember ever, claiming to be an expert on biotech.

I depend a great deal on Google to find sources and answers to questions that seem relevant. I prefer to quote (copy/paste) what I feel is relevant directly from the source rather then simply morph that into opinions and state them as facts. I always try to include the links so it is easier for the board to see if I pulled things out of context and changed the meaning or relevance.

I have followed several biotech’s in the last 3 years. I try hard to do proper DD of my own. I learned the hard way that it’s a bad idea to take what folks say as gospel. Don’t do that with anything I post. Check things for yourselves, that’s what the links are for.

Now back to the subject at hand.

What will Anavex’s next trial for Alzheimer’s look like?

Do investors here really want the next trial to include enough participants for a final Phase 3 trial that the FDA could sign off on for approval? That would almost certainly require more patients than a similar Phase 2b, would it not?

The current trial was not designed to show efficacy, it was designed to show safety, while providing inconclusive, non-statistically significant “hints” at efficacy. Can we agree on that?

I’m not sure why everyone is in such a tizzy because I’m saying nearly the exact same thing as the CEO.

“We’re trying to gather as much data as possible so we can do this properly,” Dr. Missling said. “ You can make the case that some developers have rushed into these studies after interpreting early results the wrong way. They said the glass was half-full when it was really half-empty. For us, it’s very important not to do that. We won’t go ahead with this until we are completely comfortable with what we see.”

So, does it seem logical to base a make or break Phase 2/3 trial ( which must prove efficacy) on data from a small unblinded, non-placebo controlled, underpowered, trial that was not properly designed to prove efficacy?


Based on what I have witnessed from other biotech’s I follow, I found it hard to believe that when the 300 patient Phase 2/3 was being floated that the FDA was going to be satisfied in giving the ok to market a drug that less than 400 patients on planet earth have taken, especially for mild Alzheimer’s which is frequently misdiagnosed.

Here is a list of questions I think investors should ask themselves.

Why are most trials blinded and placebo controlled? Is it a good idea to put so many funding eggs into a Phase 2/3 basket based on results from a trial that was susceptible to significant bias because it was unblinded and uncontrolled? How many different doses will the next trial have with a sample size of only 200? What if the sample size, due to multiple doses, is too small for statistical significance?

It’s encouraging that multiple data points were positive, but have a look at the following link and ask yourself if the potential for bias (even unintentional) was there, since the raters knew which patients were on which dose.


http://www.medafile.com/cln/ADCSADLm.htm


My guess, (and it is a guess) is that reducing the patient estimates from 300 to 200 was a hint that the next trial will be a Phase 2b properly designed trial to test for efficacy rather than a Phase 2/3. I doubt management would come out and state it clearly, just like they didn’t tell investors that 3 trials were not going to start last year. It would make it harder to raise funds from LPC if management was completely transparent with investors.






“The extension study will close out in November 2018. Anavex hopes to begin the drug’s next phase of development before then, with a phase 2/3 study of about 200 patients.

https://www.mdedge.com/clinicalneurologynews/article/152595/alzheimers-cognition/development-sigma-1-receptor-agonist?channel=180

Wouldn’t “proof” from a Phase 2b trial, that was properly designed, accomplish the same thing as a Phase 2/3 trial and do it with less risk and expense? Why is it sacrilege to suggest it’s more prudent to run a 2b then a 2/3 trial?