So one question that I have always had is that if MYL were to also receive approval for a 40 mg thrice weekly dosing for generic Copaxone, would we not expect approval of their daily 20 mg dosing first, or could they come simultaneously.
I know there are a few players out there for the 40 mg thrice weekly dosing, but if I am the FDA I would think I would first look at the competitors' 20 g daily dosing, as it has been in front of the FDA much longer, rather than approve a competitors' daily and thrice weekly product at the same time.
Approving the 20 mg first would allow the FDA time to evaluate post-marketing events before granting further approval of a 40 mg thrice weekly product and possibly saving face for the FDA if there are post-marketing issues with the 20 mg daily product.
Also, perhaps no news is good news, but I have not seen any mention of post-marketing issues with Glatopa except for the typical, anecdotal complaints.
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