Replies to post #108852 on Biotech Values

[DewDiligence]

Do you recall any company coming out and publicly criticizing the FDA, then getting approval in the short term 3 to 12 months?

There are very few cases where a drug/biotech company has publicly criticized the FDA…period. The only case I know of that even remotely fits your description is Omnitrope, where NVS sued to force the FDA to render a decision on NVS’ 505b2 application.

The Omnitrope case was probably a singular event, however. The FDA claimed it did not have the statutory authority to approve Omnitrope under the 505b2 regs, but the Court said it did and the FDA then approved it.