Such opinion will also list any variations which are not considered approvable. |
And is, in fact, approvable as a practical officer and soldier, by the strictest judge then living. |
The Company submitted its response to the second approvable letter last September and this response has been acknowledged as complete by the FDA, allowing for the Class 2 review. |
In addition, the number of approvable letters, which state what conditions must be met for a drug to be approved increased. |
In November 2006, the FDA advised Neurochem that the response submitted in October was complete, as it responded to all of the items raised in the August approvable letter. |
According to Spain, the reason for using a soft loan is simply that they thought it would be more easily approvable by the Commission. |