Biotech Values

[RockRat]

Fine. So which of these do you think is the issue?

>>C. When is an amendment classified as minor?

Except for those amendments that are classified as major or telephone, amendments will be designated as minor. Minor amendments often consist of deficiencies that are outside the control of the applicant or deficiencies that are more easily addressed than those in a major amendment. Though most amendments will likely be minor, some examples include, but are not limited to:

1. Deficiencies in the drug master file (DMF)

2. Problems regarding good manufacturing practices (GMPs)

3. Incomplete dissolution data

4. Labeling deficiencies that have not been adequately addressed <<

Obviously #3 is not in play. I doubt #1 or #4 would be difficult for Teva to resolve. If there's a significant problem here for Teva, it is #2, IMO. What do you think?

Regards, RockRat