Biotech Values

[tinkershaw]

Dew,

After taking a fresh look at it. You are correct, that is exactly what Teva was stating that Marth was trying to convince listeners that the involvement of OBP means sameness has been established and hence the review of the ANDA by the Office of Generic Drugs (OGD) is complete

Here is the primary statement again from Teva:

We recently met with representatives of the FDA to discuss the status of our ANDA during the meeting we confirmed that our version of generic lovenox meets the FDA's criteria to demonstrate chemical sameness and accordingly that data related to immunogenicity are currently under review at the office of biological products."

Just read it, brilliant! That is exactly what they were doing. And as you addressed, that logic is bunk. They are stating that since the drug is at OBP that must mean that OGD has all but approved it for chemical sameness. But there is no information at all that this is the case, or that moving it to OBP is even a requirement that sameness first be found.

You got it! Brilliant Dew! Maybe it took a fevered brain to see it as well as you did, after the fact.

Tinker