>PP – e.g. the more-than-passing comparison of their new free Cu tester to cholesterol testers in revenue stream. I can't think of any blood tester other than blood sugar that is more used in the US. Substantial hubris to assume that the Cu tester will ever get to that level of usage<
This was one of the two “highlights” of the webcast, IMO. The other was Kanzer’s assertion that PP was unable to reinstate its revoked EU patent “because the clock ran out on us.”
>In the CC they say explicitly that they are planning to sell their dry AMD treatment assuming GRAS status (so no NDA needed) but sold via prescription. I do not understand the regulations here…<
Kanzer says there’s some provision in Section 5 of the ODA that allows this zinc widget to be sold as a medical food. Whether there is or isn’t such a provision is immaterial, IMO, because a product based on GRAS will never get premium pricing. In all likelihood, this product will end up being sold at GNC—if it is even sold at all. Regards, Dew
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