Anavex Life Sciences Corp (AVXL)

[frrol]

Regarding TEAEs, the most recent SA article's author said the company made a mistake in the Dec 1 readout PR which read: "The incidence of treatment emergent adverse events (TEAEs) was similar in the active and placebo arms with dizziness being the most common TEAE." A couple things on this: our CTAD deck showed the dizziness stats themselves, so the PR was wrong vs the deck: dizziness was not "similar". But such a mistake is relatively minor, because we were shown the data and could tell the PR was simply poorly written. (Ie, careful investors weren't completely misled.) The mention of "dizziness" was just really in the wrong sentence. (It should have been in the next sentence, regarding those TAEAs >=7.5% threshold.)

The company states that the TEAEs "were predominantly mild or moderate". This just stays in the bounds of 'true'. Dizziness is just one of many of the observed AEs, hence "predominantly". But while dizziness is not like "heart attack", it does increase fall risk (very important in geriatric patients). And it did cause titrations downward, which reduces drug exposure and potential efficacy. It also made trial results harder to interpret for designing dosing (very important for any drug, and a challenge for most future 2-73 trials). So dizziness is important.

But again, better than "heart attacks", or "ARIAs".