Have to agree with you that no one really knows what they mean. Looking closer, if anyone screwed up, it's Tercica in their release stating orphan status for 'severe' primary IGFD. Re-reading their FDA letter, it is basically a mirror image of that of Iplex and I'd of thought it meant orphan status for severe primary IGF-1 (primary IGFD)...exactly the same designation for Iplex approval. If it's truly per the word of Tercica's PR, it would imply they have approval for primary IGFD, but only given orphan for severe primary IGF-1 (the 6000 market of 3 SD below the mean) - then per INSM PR, FDA gave them orphan for primary IGFD (the 30000 market of 2 SD below the mean).
I would normally think that Tercica screwed up their PR and should have just said orphan for primary IGFD just like Insmed, but then this statement I clipped below contradicts that theory as it says they are still trying to get approval for primary IGFD usage!?!?! Perhaps they got additional clarification over the letter in regards to what group the orphan status actually covered, but I don't see that. I think this is actually both companies fighting for the same market, that of 30000 US 30000 EUR....sure be nice if INSM talked about it though, they haven't thrown numbers or additional information out at all - 240million is a far cry from 1.2 billion.
The company plans to broaden the indicated use for Increlex in the U.S. and the EU with supplemental applications, pending positive results of ongoing clinical trials evaluating Increlex in children with Primary IGFD. Primary IGFD is characterized by height and IGF-1 levels that are two standard deviations below the mean, in spite of normal or elevated growth hormone levels.
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