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Kiwi, KM has been hinting aggressively about a

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Laurent Maldague   Thursday, 11/25/21 08:00:07 PM
Re: Whalatane post# 361327
Post # of 361856 
Kiwi, KM has been hinting aggressively about a new formulation in the last three or so investor conferences, specifically saying if successful, it'd be the "silver bullet" to thwart generics.

The infringement lawsuit will only go at the pace of the court system, and there's no telling how it plays out. It's only sensible to have alternative strategies.

Since KM hasn't divulged the details, all I can do is speculate about his plans. If the once-daily Mochida formulation can get the CVD label, Amarin will essentially product hop to this new formulation where there won't be generics and thus no auto-switch. Mochida has finished two trials for this formulation, but I won't pretend to know what additional steps are required to get FDA approval. Obviously if the FDA requires a CVOT, this won't be a viable strategy. However, if Amarin only needs to prove equivalence in terms of peak/duration of EPA levels (check out In Vitro/Vico Correlations), then perhaps we can get approval much quicker.





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