Replies to post #329 on Insmed Inc (INSM)

[coinstarz]

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.

[rfoable1]

ioio, rstor,
rstor has it right.

There's no difference between the approvals.

The FDA final approval letters & associated package insert texts are the final standard of what is approved and what is subject to orphan exclusivity.

The two FDA approval letters are quite clear - the approved indication for each drug is "severe primary IGFD". Both approval letters state that the product is granted approval with orphan status (7 year exclusivity) "for the indication being approved".

FDA was a bit sloppy in appending the "(primary IGFD)" part in each letter - omitting the term "severe" in that parenthetic part of each letter.

However, BOTH approval letters and BOTH press releases parrotted the FDA wording which omitted the term "severe" in one spot. Public companies are normally very careful to conform their approval press releases to exactly what the FDA letter states. In both these cases, FDA omitted the term "severe" in that one spot - the companies were just faithfully requoting exactly what FDA wrote.

Both companies know perfectly well that they are not yet approved for "primary IGFD" (non-severe). Neither is approved yet to market for the 30,000 primary IGFD kids in the US; and only TRCA has announced a formal application in the E.U. to pursue the other ~30,000 pateinst with "primary IGFD" there, but that approval will likely take at least 6-9 months.

Meanwhile, Insmed has not submitted for approval in Europe for primary IGFD (non-severe). They either prefer to go after alternate indications with much bigger markets than 30,000 patients, or, they are just a bit behind getting their EMEA (european fda equivalent body) submission in.
cheers