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To: shakedown who wrote (8092)	11/23/2001 10:37:37 AM
From: Ron Nairn	Respond to of 14101

Excellent find Warren. Makes sense to me. A must read for all. Looks like we're on the home stretch. Rondo

To: shakedown who wrote (8092)	11/23/2001 11:13:04 AM
From: Joe Krupa	Read Replies (2) \| Respond to of 14101

Warren, You da man! "When the technical reviews are completed, each reviewer develops a written evaluation of the NDA that presents their conclusions and their recommendations on the application. The division director or office director then evaluates the reviews and recommendations and decides the action that the division will take on the application. The result is an action letter that provides an approval, approvable or non-approvable decision and a justification for that recommendation." In order for the plant to be inspected, DMX has obviously passed through this stage ("Reviews Complete and Acceptable"), and having done so, must have been assigned one of the three outcomes: 1)Approval 2)Approvable letter 3)Non-approvable We know it's not #1. We also know it's not #3 as the plant inspection does not take place. Therefore, it can be nothing other than #2, an "Approvable" letter. That is huge. I know from following (with envy) many other companies that have received approvable letters over the past few years, that it is then only a matter of months before the final approval is given. Thanks again Warren. joe

To: shakedown who wrote (8092)	11/23/2001 11:32:56 AM
From: Cal Gary	Respond to of 14101

NICE link Warren! "That's a nice boat." "That's a nice boat." "That's a nice boat." "That's a nice boat." Rick Mercer FDA: 'great comfort and great confidence'

To: shakedown who wrote (8092)	11/23/2001 12:32:32 PM
From: john.d	Respond to of 14101

Nice find Warren, I like this part the best under the "NDA actions" box, 'Once the division director (or office director, as appropriate) signs an approval action letter, the product can be legally marketed starting that day in the United States' John.