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rafunrafun

01/25/22 10:26 AM

#367380 RE: marjac #367370

M-

Note that the product could meet FDA standards but still violate consumer fraud laws, if the generic manufacturer omits material facts about the product from consumers, where knowledge of those facts would affect the consumer's decision to use the product.

IMO the Generics are bullet proof here. Any bioequiveloncy claim they make is based on FDA's (inadequate, IMO) rules, which they (Generics) have complied with.

Generics keep gaming the system, successfully. They play within rules that the system has set. As much as it pains me to say, the Generics aren't our enemy; the system is.

The same system that allows them to sell via "skinny label".

The same system that allowed Du to overrule the USPTO.

The same system that tells consumers that a bright-yellow, rotten-smelling, untested capsule is the same as a crystal-clear, odor-free, 7-year-tested capsule.
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newman2021

01/25/22 10:32 AM

#367382 RE: marjac #367370

marjac, could you please connect with Demmer and seek his support to push the board or executives to garner support for your case instead of you alone carrying all their loads, thanks!