Replies to post #334 on Insmed Inc (INSM)

[rstor1]

+++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.+++

Baxter is quite close-mouthed about this. His response to my questions about it was "We have not commented on the EMEA filing yet."

I was trying to find out if they were waiting for a European partner for the filing, as has been speculated.

Read what you will in it.

Regards,
bob

[Deewar25]

Unless you actually know and understand the science, I still don't agree with what you are saying - all prior press releases from both companies also state 'severe primary IGF-1 (Primary IGFD) - this can't have possibly been omitted by INSM, TRCA and FDA (by omitting 'severe' in the brackets). Tercica goes on to state severe primary IGF-1 is 2 SD, while severe primary IGFD is 3 SD below mean. These must be 2 different things (while at the same time, it does puzzle me that TRCA is doing those extra trials for 'primary IGFD')!!! My head hurts now!

Insmed Incorporated (NASDAQ: INSM - News) announced today the United States Food and Drug Administration (FDA) approved IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.