Anavex Life Sciences Corp (AVXL)

[nidan7500]

whip...thx..

So then, on the SOON scale of time keeping according to FDA SPEAK when initial NDA discussion/agreement is done we have a process which defaults to ..."if you do not hear from us w/in 30 days"...then you can assume it is a GO.???Do I have that right? Hence..and so, (boys and girls) that is how we get ...Any day now.

Just a quick read?

When discussing the planned submission of these applications at a presubmission meeting, the 78 FDA and the applicant reach agreements regarding the content of a complete application for the 79 proposed indication(s) as well as agreements, if any, on submission of minor components that 80 may be submitted not later than 30 calendar days after submission of the original application. 81 Unless the applicant and the FDA have agreed at the presubmission meeting to delayed 82 submission of certain components of the application, the FDA expects applications to be 83 complete at the time of submission.10 If agreed-upon delayed minor components are not 84 received within 30 calendar days after receipt of the original application, the application will be 85 considered incomplete. Incomplete applications may be refused for filing. A rolling review 86 permitted under fast track designation has similar obligations.11 87 88 Documenting agreements reached at presubmission meetings for drug products that are part of 89 the Program, then ensuring that only agreed-upon components are submitted after receipt of the 90 original application and that these agreed-upon components are received within the 30-day 91 window and are complete, has added significant complexity to a determination that an 92 application is complete.