Biotech Values

[DewDiligence]

FDA obviously knows the full detail of the mfg process for Copaxone. They had to approve it as part of the approval.

Not necessarily. Copaxone was approved by the FDA in 1996 via an ordinary NDA. The statutory requirements for the FDA to approve an NDA are safety and (substantial evidence of) effectiveness—not full characterization of the compound and the production process.