lol I just keep laughing those severe severe. severe primary, and primary severe. I lost! I guess even Insmed and Tercica and FDA get confused too. There is a definition about severe and primary according to the companies.
You're right on the target. If it's good for Increlex, then it is better for iPlex. I guess the wording of "severe or no severe" is very important for both of Increlex and iPlex. If FDA did make a mistake on the word of severe (forgot to give severe to iPlex for orphan status, then iPlex surely got the best deal. And too late to change it for FDA. I know Tercica is doing trial for Increlex for primary IGF-1, it will be harder to get FDA approval since FDA already granted orphan primary IGFD to Insmed.
Nice catch, Deewar25, excellent! I never thought those. I will check FDA papers this weekend and also ask others for opinion.
Peace!
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