Anavex Life Sciences Corp (AVXL)

[Investor2014]

There is actual data on titration available too!

That is the available data.

48 dose arm patients were left on their 10mg starting dose and not titrated up. Another 338 - 263 = 75 were titrated down again from whatever dose they may have reached.

Hence that is about 123 patients that did not reach their target dose!

One key reason for not reaching the intended target dose in more than 1/3 of patients, is of course dizziness and other tolerability issues.

No up titration and using down titration helped insure that there would be fewer patients with dizziness and falls than there otherwise would have been.

So we are left with no distinct 30mg and 50mg cohorts, which in trials is called is called the Titration Paradox. Paradox because titration is good for optimising dose and for avoiding AEs, but not so good for keeping arms balanced as per random assignment and thus throwing off statistical plan validity.

As a results, I believe we must wait for the full pre-specified subgroup analysis, so I would say not to expect a TLR/TLD refresh.

Next stop after that analysis is complete will be guidance from regulators and potential filing for approval. For investors it will be the peer reviewed paper - all imo of course with a high likelihood of being correct!

Does that make sense and if not, please precisely explain why not?