Application - Initial Filing

In the table above:

• Events 01-03 are associated with an Application - Initial Filing.
• Event-01 comprises sequences 0001-0003 and was submitted to the regulatory agency for approval on January 1, 2007. It has not yet received approval.
• Event-02 comprises sequences 0004 and 0005 and was submitted to the regulatory agency February 2, 2007. It received approval from the agency February 15, 2007.
• Event-03 comprises sequence 0006 and was submitted to the regulatory agency March 1, 2007. It has not yet received approval.

When you add an event to the approved view, the following occur:

• The first application approval date is set.
• The event is closed.
• The event status is changed to Approved with the appropriate time stamp.
• The sequence statuses are changed to Approved with the appropriate time stamp.
• Any pending product details are approved.
• The event is added to the Approved Views tab. Application - Initial Filing

In the table above:

— Events 01-03 are associated with an Application - Initial Filing.

— Event-01 comprises sequences 0001-0003 and was submitted to the regulatory agency for approval on January 1, 2007. It has not yet received approval.

— Event-02 comprises sequences 0004 and 0005 and was submitted to the regulatory agency February 2, 2007. It received approval from the agency February 15, 2007.

— Event-03 comprises sequence 0006 and was submitted to the regulatory agency March 1, 2007. It has not yet received approval.

When you add an event to the approved view, the following occur:

— The first application approval date is set.

— The event is closed.

— The event status is changed to Approved with the appropriate time stamp.

— The sequence statuses are changed to Approved with the appropriate time stamp. — Any pending product details are approved.

— The event is added to the Approved Views tab.

Add Events to the Approved Status View

You can add an event to the Approved status view in one of the following ways.

— Using the Update Status wizard. For an event to be added to the Approved view successfully, at least one country associated with the event must be unlocked.

— Manually adding an event to the Approved view on the Event Attributes page. For an event to be added to the Approved view successfully, an event should be a closed as an approved event.

Manually Add an Event to the Approved Status View

You can add an event to the Approved status view if the event is closed as an 'approved' event.

To manually add an event to the Approved status view:

1. Click a link for the event you want to add to the Approved status view. The Event Attributes page opens.
2. Click Add Approved.
3. Choose the applicable procedure to enter an electronic signature for entities:

View an Event in the Approved Status View

You can view events with the approved status from several links in Ennov InSight .

To view an approved event status:

1. On the Ennov InSight Home page, click the Approved Views tab.
2. Click a link for the approved event you want to view.

   The Approved Event Status View page opens.

3. Right-click the root in the assembly tree and choose Expand Range to see the submission.

Remove an Event from the Approved Status View

You can remove an event from the approved status view for several reasons:

— It was added in anticipation of approval that was not received.

— An RTF (refusal to file) was received. — It was added accidentally.

To remove an event from the approved status view:

1. Click a link for the event you want to remove from the approved status view. The Event Attributes page opens.
2. Click Remove Approved.
3. Choose the applicable procedure to enter an electronic signature for entities: