Biotech Values

[tinkershaw]

This sentence sure reads to me that Teva believes it has met the 5 criteria. Yet you say:

That is because Teva qualified what it meant by meeting all 5 criteria in the second part of its statement. It "believes" it has met the 5 criteria...and approval is appropriate because:"

STOP THE TAPE. Approval is appropriate for reasons other than meeting the 5 criteria??? It is double speak. It is like the definition of what "is" is. It is qualifying what it means by meeting the 5 criteria, as the criteria are simply a method for determining "sameness" and Teva believes it has sameness because of how it qualifies the paragraph.

As we have seen with Teva over and over again, double speak. At least that is how I read it. All Teva had to say was they believe that their drug meets the 5 criteria laid down by the FDA and that Teva believes that copaxone is more complicated, so don't read anything into the copaxone ANDA simply because lovenox was approved.

That says it all, but instead of just stating "Teva believes that it has met the 5 criteria" (and that is what is required for approval and everyone knows what the 5 criteria are) Teva then went on to say that approval IS APPROPRIATE BECAUSE...Which is nonsense in context, except as a qualification, because approval is only appropriate if the 5 criteria are met to begin with AND NOTHING ELSE IS REQUIRED.

Read that again, the FDA said that a generic lovenox will be approved if it meets the 5 criteria. End of discussion. Right? Not for Teva, they have to qualify it by saying approval is appropriate {BECAUSE OF REASONS OTHER THAN THE 5 CRITERIA} set out by the FDA.

Since approval is only appropriate if the 5 criteria are met, then why the heck is Teva then specifying that approval is appropriate based upon these other reasons?

If that is not double talk and double speak to articulate a very simple statement: "we believe our drug meets the 5 criteria" then I have never seen double speak.

Tinker