Replies to post #102119 on Biotech Values

[DewDiligence]

wouldn't this mean that if Teva's [Lovenox] product does not show immunogenicity it will be approved because if there is no immunogenicity it de facto proves purity?

To get FDA approval, Teva has to show sameness according to the FDA’s five-point requirement shown in the table in #msg-52582225.

[rkrw]

Absolutely, you can drink it, ahhh, nothing like Poland Springs water.

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