Replies to post #502472 on Anavex Life Sciences Corp (AVXL)

[falconer66a]

Now, the Blarcamesine Ease of Use Factor

Interesting focus of Dr. Grimmer's presentation at the European Alzheimer’s conference:

The advantage for the family would be less caregiver stress, and likely less financial strain with no need to arrange for constant transportation and no impact on own work schedule.

The advantage for the physician would be no logistical barriers to treatment with no need to arrange or schedule complex, invasive PET scans, lumbar puncture (spinal tap) or repeated MRIs.

In summary, the impact on daily life is favorable with oral Alzheimer's treatment blarcamesine. It maintains independence of loved ones longer, safely, giving better outcomes, while allowing efficiency and convenience for patients and families.

He seems to imply, contend, or presume that both blarcamesine and the approved monoclonal antibody drugs (MABs) successfully treat Alzheimer’s. But the MABs present very difficult, expensive, and procedurally complicated lab-based treatment monitoring protocols. Instead, blarcamesine is simply taken at home, each day, with a glass of water.

Let’s see how this information gets reported in commentaries derived from the conference.

How will both patients and physicians respond to this information, once it's known?

[Guzzi62]

I hope Alz US gets this showed down their throats.

Can some of you US guys please forward the program to them, call CNN & Fox and tell them about it.

[boi568]

Here's the most useful point Grimmer made:

"The trial inclusion requirements were readily manageable for both the patients and the families with no mandatory invasive assessments. The emphasis was on the National Institute on Aging (NIA)–AA criteria for diagnosis of early-stage mild-dementia due to AD."

The EMA stated in November 2024 that "NIA-AA sets of criteria are accepted by the EMA guideline on clinical studies for AD medicines in effect since 2018."

https://www.ema.europa.eu/en/documents/report/alzheimers-disease-eu-horizon-scanning-report_en.pdf

So the 2b/3 trial, as described by Grimmer, is considered by the EMA to be an early-stage AD trial. These facts document Anavex's position that the EMA does not require the company to meet its ADL co-primary endpoint in the MAA now being evaluated.