Deewar,
I would not be so confident that FDA could not make such an oversight. It's completely possible. FDA just did not see the slightly different wording as a big deal - they saw the phrase as simply clarifying that they recognize the meaning of the acronym "IGFD". We may think it's a big oversight - but so what? It's moot since the exact same wording was issued to both companies by FDA. The two public companies dare not state a single word different from what FDA stated in their published approval letters, so they replicated exactly what they were given in their respective press releases. No difference/no advantage for either company.
They are clearly two different cuts of the IGFD market. "severe primary" is just a subset of "primary". No complex science in that. Tercica has, I think, rather clearly stated the difference, exactly as you have stated - growth velocity outside 3SD's is "severe". Outside 2SDs is not "severe". FDA as well as Dr Underwood and several other experts would have jumped all over Tercica if they saw that Tercica was publicly mis-identifying the statistical basis of the indications.
hang in.
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