Biotech Values

[DewDiligence]

MNTA TEVA etc. – Addendum on Bill Marth’s comments: When Congress finally gets around to passing FoB legislation, they need to also address the workflow at the FDA for complex generics such as Lovenox and Copaxone that are regulated as small-molecule drugs.

If the FDA is going to spend 3-5 years reviewing each ANDA because OGD and the Office of New Drugs keep shuffling the papers back and forth, the potential benefit to society from having generics for these large-selling drugs will be greatly reduced.