Biotech Values

[DewDiligence]

Why the Lovenox ANDA’s have taken so long for the FDA to process:

There isn’t a good way today of handling these products within the Agency if you follow the flow of what goes on… We submit… eventually we get accepted [for review]… once we get the acceptance, there’s a series of questions… we answer those questions… the answers go into OGD [Office of Generic Drugs]… OGD looks at it, throws it over to [Office of] New Drugs for a consult… New Drugs says, “There’s no PDUFA fee so I’ll put it over here”… they eventually get to it… they answer it… they send it back to OGD… OGD may have further questions for New Drugs… they send it back to New Drugs… then it eventually comes back to use for a response and the whole cycle starts again.

—Bill Marth, CEO, Teva North America (1/8/09 at the GS conference)