Replies to post #113133 on Biotech Values

[marthambles]

As much as I would like to agree with Dew, I'm not sure how one can square his conclusion with the following quote from the FDA policy statement regarding amendments:

Minor amendments have a higher priority than major amendments because they often mean an application is close to approval and should, therefore, be given priority.

[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

[alertmeipp]

Not sure why the street is so forgiving to TEVA while being so hash on MNTA...

Teva said one month after MNTA's approval, they expect theirs.
Teva said approval decision by end of 2010.
Teva said approval decision by month end. Less confident on approval.
Teva now says getting close.


If other companies got this letter after all these promises, pretty much it will get crashed.