Replies to post #336 on Insmed Inc (INSM)

[rfoable1]

rstor,
Yeah - what's up there I'm not sure.
It's rare that any pharma or biotech company does not want whatever PR advantage it can get - and filing for approval in EU certainly would be significant.

In fact, so significant that one would think it would be a required public statement as a clear "material event".

I've heard rumors that rarely a "material event" may not be announced for a short while on the theory that, as long as NOONE outside the company (other than a party trusted to maintain absolute confidentiality such as a gov't regulatory body) knows of it, then there is no commercial advantage/disadvantage and it may not be considered essential to reveal it. The risks of that approach seem huge - the chances of a leak are too great. I've not seen a clear example of that, and I doubt it has happened. So I'm assuming that Insmed has not in fact filed with EMEA as yet.

Insmed may be holding off on the EU filing to enable a European partner to get on board so they can make a joint press release. But that strikes me as weak. At some point, one would think that the commercial benefits of starting the approval review clock at the EMEA would outweigh any PR advantage in waiting for a partner.

UNLESS that partner was a HUGE international pharma or biotech that has the clout to insist that their final partnership agreement with Insmed is inked before anything about Europe (or any other market) gets publicized. Such as rights to several big-market indications (such as severe insulin insensitivity in both Types I & II diabetes) FOR iPlex are also being negotiated.

It is also entirely possible that Insmed is negotiating with a big pharma for world-wide rights for one or more indications - including the US. Until iPlex launches I'll bet some big pharmas will continue to sniff around Insmed.

It would be no PR problem if Insmed revealed just before the 2Q2006 launch that they are NOT going to launch it in the US on their own - because they've licensed it out to Amgen, Novartis, or similar!

Interesting... we'll see.

Boy these are nice puzzles to ponder - compared to "will Insmed ever get it approved?" !!

All the best.