Biotech Values

[tinkershaw]

RockRat,

I have not, but I will by this weekend. Thanks for the link.

I hope your opinion of the rigidity of the entire document is true, as I do not believe that Teva would meet the first 3 of the 5 requirements cited from Dew's link on that basis. However, the longer and more detailed a rule making document, the more ambiguity will be found by a well funded law firm looking for the same.

Any of the rules specified also have to meet the enabling legislation and the purpose of the rule making to begin with.

What I think Teva is doing is stating that many of these rules are extraneous and not necessary, and that Teva has met all reasonable and necessary requirements, and having done so, their application must fit within the criteria created, and if not, the criteria needs to bend.

As a lawyer, I can put the FDA on the stand and ask them why "X" really matters when Teva has met "Y". The FDA will need to articulate reasonably why this is so. They don't have to be right, but they have to be rational about it.

Thanks for the link and RockRat and the indepth analysis you have presented us. I'll go through the long version this weekend.

Tinker