Anavex Life Sciences Corp (AVXL)

[Fireman02360]

RE:

Today's FDA announcement would seem to make that guess zero
while awaiting comment period.

You are clearly wrong on this. From the FDA PR today:

"FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in FDA’s guidances means that something is suggested or
recommended, but not required"

Also:

"This draft guidance, when finalized, will represent the current thinking of the Food and Drug
Administration (FDA or Agency) on this topic. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. To discuss an alternative approach,
contact the FDA staff responsible for this guidance as listed on the title page. "


I do have much experience with Federal Government "Draft Documents" in the form of NWCG (National Wildfire Coordinating Group) Standards for Wildland Firefighter Training. I am an instructor for many different NWCG training courses and just because something is in "Draft" version does not mean we stop training firefighters, we just simply adjust the training to meet these recommendations until the more formal "Final" training curriculum is commented on,updated and distributed through the National Cache out of Boise, Idaho. Often, some of my classes I instruct will be the "Guinea Pig" for such changes and I give feed-back to the NWCG Training Council.

I truly believe Anavex will be the "Guinea Pig" for these FDA changes. I makes me even more confident that this is taking place with the hire of Dr. Fadrin. Put the puzzle pieces together, its not that hard.