Anavex Life Sciences Corp (AVXL)

[skitahoe]

I'll be the first to admit that I've never created an NDA, BLA, MAA, etc but I think we should all understand how difficult, and massive, these documents are. In NWBO's recent UK submission it consisted of 1.7 million pages, and they already had the commercial production facility approved. I don't know that AVXL's would be that big, but even it it's 1 million, it's a massive effort. Companies take years in building such documents, but rarely discuss them, beyond long range guidance like, we're planning to submit in 4th quarter, etc.

My point is that all this is happening unseen, it very well may be discussed with regulators and determined that major revisions should be made to meet what they're suggesting. The point is, when a submission is made, the company will have achieved a major goal. I doubt if we'll be told we're weeks, or months away from a submission, but when it's done, it will be huge news.

Gary