Biotech Values

[DewDiligence]

The FDA’s rejection of Teva’s 4th Copaxone CP (which had a response deadline last Friday) without specific comments about the reason for the rejection is essentially neutral for NVS/MNTA and MYL. It merely means the FDA is still reviewing the two Copaxone ANDAs.

Will Teva now submit a fifth Copaxone CP? There ought to be a statutory limit on how many times the same argument can be pressed, requiring the time of FDA staffers to respond. (If this were litigation, Teva would probably have been sanctioned by now.)