Insmed Inc (INSM)

[rod5247]

E,

DNA also has use patents that may have to be negotiated for ex-EU. I did not go into great detail but do know that CEPH or DNA or both will need to be negotiated with in order for Iplex to market for ALS. If the trial shows efficacy, I do not see a problem there.

Preliminary efficacy is coming from two sources, the Italian ALS forum and Insmed and both are careful to downplay the signifigance as not to build hope or create hype but it is encouraging. As far as the time to see results, they can be seen by the patients in weeks. The MMD trials are only 12 weeks and long enough for significant data collection on a reduced dose of 1 mg. Don't you think those patients were feeling a difference long before the 12 weeks ended? I would assume the Docs for the Italian patients are titrating the dose up to maximum ASAP. The ALS news was announced January but it was in Italian newspapers by Nov. 06. There could easily be 18 patients on Iplex for three months already.

Don't forget the Mayo Phase III on half the dose of Iplex. Results this summer.

Here is some speculation, will the large Italian trial currently being designed be a Phase II or Phase III? If Phase II, it would definatly be Phase III enabling at some point. If Phase III, then the door is open for DNA or CEPH or both to opt-in. Wouldn't that be one hell of a surprise!!

You can take it to the bank that Insmed and Italy are in discussions on the design of an ALS trial involving 100-200 patients and you can bet your sweet a$$ it aint Phase I.

Rod