Rivulet Media Inc (fka RIVU)

[rverboatgambler]

I went thru this dance with Arena Pharma
They had to re enter data to the FDA, that most thought had already have been covered.

One day they had an eight person FDA panel who were asking questions about the frequency of tumors appearing in the breasts of the female test mice ( I'm not making this up)...

....and the Arena doctor responsible for the correct answer was a bit puzzled, and didn't have his data in front of him on the day of the panel.(Since he felt it had already been adequately covered in previous meetings with the FDA.)

That simple mis-step caused Arena to be held up for "label approval" for an extra year.

Also, there is a quiet rule that these Pharmas are under- a rule where they can't even whisper a clue to the public as they go thru the routine.

The FDA can get awfully Aanul about the details.

: /
just my humble two cents.

Rver