I don't normally do this and I apologize for staying on the posting sidelines, but some might want to go back and read some of my posts over the last year and a half. For example, this one was just recently explained by our new leadership.
And for anyone who thinks the clinical trials web site is the first thing updated...oh, how nefarious!
Happy Thanksgiving to all (assuming that is indeed the reason I'm seeing so little activity).
Hi Bwd. I hesitate to put words into your mouth - but since you seem to be reluctant to I'll take a stab at it, and give you the option of telling me if they're the right words :-)
I guess you're pointing out that although Arikace is being tested against Tobi in the ongoing Cystic Fibrosis clinical trial, to all intents and purposes the CF indication should be viewed in the same manner as NTM and non-CF bronchiectasis - a condition for which there are presently NO therapies available.
Tobi, the present gold standard therapy, delivers a significant improvement in quality of life for the first four-week period of therapy only. Insmed is hoping to position Arikace as the first therapy available to the CF patient population which delivers a significant and sustained improvement in quality of life.
Hence the open label follow-on phase of the study over a period of 96 weeks.
Could I invite you to put your own words into your mouth on a couple of issues?
1. What do you make of the reference to a change of strategy?
I note that the Company seems to have quietly dropped the suggestion that they would look for a partner with which to commercialise Arikace outside of the US.
2. How likely do you think it is that Arikace will be a beneficiary of the new legislation to speed the availability of breakthrough therapies?
A US marketing authorisation on the back of the EU CF clinical trial is the obvious potential development, but what of the possibility of a marketing authorisation for non-CF bronchiectasis on the basis of the 2009 Phase II data combined with the more recent CF data?