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Friday, 02/01/2019 10:19:15 PM

Friday, February 01, 2019 10:19:15 PM

Post# of 9147
Very interesting and revealing post Maumar. So all the theories about Roche not seeking FDA approval of SQ Herceptin because the patents were expiring later in the US than in the EU were incorrect. In reality Roche had been told by the FDA that they were unlikely to approve SQ Herceptin presumably because of titer concerns. I guess they have changed their tone because of the success of SQ Herceptin in the EU without seemingly any side effects.

I hope the FDA aren’t going to take a similar hard line on the new Enhanze SQ candidates or HALO is in big trouble.
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