Biotech Values

[biomaven0]

Of interest is this nugget from the FDA in its response to the Citizen's Petition:

Based on current relevant scientific data and information and our scientific experience and
expertise, we conclude that it is not necessary to completely characterize all the different
polysaccharide sequences of enoxaparin. Our finding of sameness for enoxaparin is not based
solely on the equivalence in molecular weight, anti-Xa activity, and/or anti-Xa/anti-lla ratio. We
conclude that the five criteria described in section III provide suffcient information to demonstrate
active ingredient sameness. Such a showing demo

So that suggests to me that complete characterization is not a requirement here.

My own take is that the FDA has now provided a roadmap to approval, and at some point Teva will indeed be able to comply. But my guess is that their current attempt (unless they are very lucky) will be found to fall short, and they will need to try again - that would entail something like 2 years or longer before approval.

Peter