Replies to post #64161 on Biotech Values

[rkrw]

There wouldn't be any standard time a CP could delay an approval. fda is a blackbox, how to know if there was even any delay?

But I think rest assured teva will pull out all stops including CP's.

Flat staffing at OGD could certainly slow things down.

No doubt lots of money is on the line.

[ThomasS]

MNTA: "In a general way, how will it affect "follow on" biologics that involve a highly characterized (in terms of glycosylation) small protein such as Copaxone?"
I'm sure you meant a "complex drug," as opposed to a small protein drug, as COPAXONE is not a protein in the context of traditional biologics. MNTA's FoB program with Sandoz does, however, address at least two FoB protein drugs. COPAXONE involves polypeptides; it was meant as the next stepping stone to outright protein biologics. Lovenox to Copaxone to FoB's.