Replies to post #175923 on Anavex Life Sciences Corp (AVXL)

[scottsmith]

Absolutely. The notion that wash trades are the reason for the decline of avxl fits.

“I believe there is a lot of "unhelpful" and " patently false or misleading information " info on this board”

[Amatuer17]

I bet that any approval for any indication for A2-73 will not come before 2020.

[OFP]

One of the greatest deceptions is exaggerating trial recruitment timelines and readout far into the future based on historical U.S. data. This is inappropriate because the trials are not in the U.S. and the likelihood of provisional approval is high simply because there are no effective treatments for these diseases

Those promoting a likelihood of early approval are doing so on the premises that:
1. 2-73 has already shown extraordinary efficacy results
2. Australia is "ahead of the curve" with their recently approved pathway to early approval

#1 is preposterous...no scientist (e.g. Hampel or others) would make that claim.
#2 is just Australia playing catch up with the FDA and the EU (as they directly state in a document I posted)

Can a drug be approved early? - yes, none of these agencies tie their hands. How often does it happen? Very rarely in the face of extraordinary results in diseases that have poor treatment alternatives and in populations in which recruitment is slow/difficult. 2-73 has 1 of those 3 criteria. There is no credible reason to EXPECT early approval. To say otherwise is UNHELPFUL. A rational investor would look to "historical US data" for reasonable timeline expectations.

Those that say that any approval must wait till 2020 are giving misleading information, in my opinion.

There could be data read outs in 2020 but approval requires a data read out and they'd need a read out by mid 2019 to have an approval before 2020. That is just not going to happen, they are barely getting started on trials. PDD is furthest along and the PDD registration shows hope to be done collecting data in 12/19. IF they meet that date then they should read out in early 2020...however I'd consider that best case because when is the last time AVXL met a self-declared deadline?

Once they read out, they need to show efficacy. THEN, those efficacy results would need to be so spectacular that the FDA does not require a 2nd pivotal trial (as they do for most compounds).

[OFP]

It is also very misleading to say that Donepezil is a superior S1R receptor. 2-73 has given benefit for years, months is the most anyone can expect from Donepezil. There is a conflating of efficacy and chemical binding which is very deceptive.

There is limited data to compare DZP effects to 2-73. Within that limited preclinical data DZP does outperform 2-73 in at least one model but there are no models I've seen where the reverse is true - please provide an example. This is not at all the same as conflating efficacy and chemical binding...please point to an instance where I conflated the two.

There are 2 themes in this regard that no one has addressed:
1. The weak affinity means that if 2-73 is co-administered with a higher affinity S1R agonist using the same binding site then 2-73 will be blocked in some extent from access to the site by the more tightly bound compound. This is such an elementary problem that AVXL almost certainly has data but they've chosen not to present it - a very bad sign with their history. Yet even know they are launching into another trial with DZP co-administered in a significant proportion of patients.
2. No preclinical evidence exists that 2-73 (that I know of or that anyone has presented on this board) exerts a superior agonist effect relative to known S1R agonists. This is very different from saying DZP is a superior agonist. The onus here is on the company to have an expectation of a superior effect and they have shown none. There is nothing favorably unique in the way they've shown 2-73 works.