Replies to post #169986 on Anavex Life Sciences Corp (AVXL)

[Kentucky123]

Thank you, Biostockclub, Peter Karol and others for all the work you have done on distilling the information from CTAD. For someone who is not a scientist it was and is very helpful. It is interesting to me that the tweets and articles only focus on the BP companies. Anavex was late breaking and the most promising presentation and the silence is deafening.

[F1ash]

First off, I wanted to say thanks for your recent posts. Reasonable, rational, well constructed, helpful and thorough imho.

Without wanting to denigrate the work you produced in anyway, I do feel the need to offer some input that I believe you may have overlooked or misread.

The Part A P2a trial used a crossover study with 30mg and 50mg.

Then for richness of data and analisys, 10mg and 20mg dose groups were added dividing patients into 4 dosing cohorts, which have now ended up concluding that the 50mg High cohort does best by far.

See page 17 and 42

http://anavex.com/wp-content/uploads/Anavex-Presentation-March-2018.pdf

The Part A actually consisted of 4 doses. Two IV and two oral. (Page 17)

Page 42 seems to show the two IV doses resulted in lower concentrations than the oral. (Probably roughly equivalent to the 10 and 20 mg oral doses that they added to the Part B IMHO)



“Part B: All patients on ANAVEX®2-73 oral daily doses of 10mg, 20mg, 30mg, 50mg according to pre-specified adaptive trial design implemented during Part A”

The Medium dose group of 30mg was conflated with the low dose groups of 10mg and 20mg in the 148 week data analysis (Low/Med).

I personally suspect that your counts on patients per dose may not be correct.

Here’s my rationale:

According to CT.gov the Part B was designed to be 30 and 50 mg oral only. It makes sense to me that the plan was to split it 50/50 on each dose. (16 on 30 mg and 16 on 50 mg) (ignoring the 1 dq patient)

So then there is this:


“These results closely reflect the practical course of the study where 25% of the patients remained on their initially allocated dose level of 50 mg while 75% of the total number of patients remained in the 30 mg dose level after five weeks of treatment.

https://anavex.com/wp-content/uploads/2016-07-24_Poster_AVXL_Sunday_AAIC_July_2016_Final.pdf

The concentration graph goes from 0-12 correct? There are 4 doses and the concentration is dose dependent in a somewhat predictable linear fashion correct?

12 / 4 = 3

Perhaps you might try looking at the graph where 0-3 is the 10 mg dose 3-6 is the 20 mg dose, 6-9 is 30mg and 9-12 is 50 mg.

Does that seems reasonable?

I don’t understand why they classified 4 different doses as just high and low concentration. It seems to me they might have picked a spot to split the graph where it makes the data look as positive as possible.

I always try to look for data omissions and explore the possible reasoning (besides carelessness).

Could Anavex tell investors how many patients are on each dose if your conclusion is correct that the dosing has remained constant ever since the Part b started? Why have they chosen not to reveal that information? Is it carelessness or something else?