Replies to post #454618 on Anavex Life Sciences Corp (AVXL)

[boi568]

You probably noticed in my post that I cited an intent to complete the 2b/3 OLE as a factor affecting timing.

However, Anavex has less than 50 employees, and only a subset of those will be tasked with completing regulatory AD submissions in Europe and the United States. There won't be very many key figures on that team, the people who can truly professionalize the product at the highest level.

While there will be overlaps in AD submissions, there will also be differences. There will be ongoing conversations with each group of regulators; there will be deadlines for each. Aside from the obvious potential for timing conflicts, there is a significant cost to transferring attention between equally critical projects. I expect management to minimize these concerns by working out separate pre submission timelines. That means not trying to do more at one time than can be well handled.

Larger companies do not have to make these tradeoffs, but this small pre revenue biotech must. Please don't be shocked.

[crescentmotor]

While there a some difference and extra requirements for the EMA, the bulk of the submissions should be identical or very similar.

Glad to read some additional discussion like the above this morning and information about using outside experienced contractors to assist in the preparation of the new drug applications. I found it quite appalling/depressing that the small number of available AVXL employees was a reason for delays in filing.