Anavex Life Sciences Corp (AVXL)

[Investor2014]

On examination of the poster you linked, I'd like to highlight a few other things:

5 SAEs events: 1 event during PART A (5 week), 4 events during PART
B (26 week) period.
- Delirium Grade 2: Possibly related; Delirium in patient with previous
history of delirium; Safety Review Committee (SRC) deemed likely not
related to study drug; The participant fully recovered from the delirium
but took no further part in the study.
- Delirium Grade 3: Not related
- Fractured ankle Grade 2: Not related
- Urinary tract infection Grade 2: Not related
- Hodgkin's lymphoma Grade 2: Unlikely related; Patient has developed
Hodgkin’s lymphoma. Patient’s comorbidities include Sjogren’s
syndrome, which increases the risk of lymphoma between five-and ninefold.
1 Will stay on study while undergoing radiation therapy.
With respect to AEs causality relatedness to study drug: 21% of events
were definitely/probably related; 40% of events possibly related; 39% of
events unlikely/not related.

The traditional definition of MTD was updated in the presence of
inter-patient variability. For AD patients 50.58 mg of ANAVEX 2-73 is
the maximum tolerated dose taking into account most frail patients
(5% of total patients). In half of these patients a DLT event will occur.

This to me fully accounts for the drop-outs and reasons. It also further validates that 50mg is in fact safe and tolerable even in the most frail of patients. Thus 25% were left in the 50mg dose group all through Part B and its extensions.

This was the reply from Clayton IR to my question from 1st Match 2018 as previously posted:

o For Part B portion of study, was a 1/4 of patients assigned in 4 groups to their respective 10mg, 20mg, 30mg and 50mg oral doses that they exited on from Part A and then remained on that dose throughout Part B? A: The latter. Exited Part A and remained on that dose.

In other words those on 30mg and 50mg oral dose in the Part A crossover study stayed on that dose, each 25% of the population. Those on IV 3mg and 5mg, each 25% of the population, were assigned to 10mg and 20mg oral dose and remained on that.

So I will respectfully stick with my interpretation .