The results of the clinical trial provide hope for NTM patients because this is the first drug to show efficacy against NTM in a clinical trial specifically designed to test it against the disease.
Additionally, this was a trial for patients who have already had standardized treatments which failed to convert their sputum to culture negative. The fact that in this study conversion to culture negative occurred rather quickly is very exciting
that's right: in a recent double-blind phase 2/3 study 1 in 4 recalcitrant patients were culture negative after just 28 days on trial drug, rising to 1 in 3 (so far) when additional population from an open-label study are taken into account.
meanwhile, 2-years continuous safety/efficacy data is on-hand now from similar phase III trials in patients with CF/Pa
Insmed is poised for 10-fold increase in market cap.
buy cheap now, or after another phoney dilution probably coming later this year.
Not wise to be short right now; Feds are likely to give green light to Breakthrough Status by end of next week.
· We expect to commence an additional study in the US and/or Europe in the second half of 2014.
· We expect to have dialogue with the FDA and the EMA in the next several months to discuss the regulatory pathway.
· If approved, we expect ARIKAYCE would be the first approved inhaled antibiotic treatment for NTM lung infections.
· We are developing plans to commercialize ARIKAYCE, if approved, initially in the US, in certain countries in Europe, and Canada and eventually Japan.
· Granted orphan drug designation in Europe and the US.
· Granted QIDP designation, which includes Priority Review, by the FDA in June 2013.
· Granted Fast Track designation by the FDA in June 2013 which permits a rolling submission of an NDA.
· Applied for Breakthrough Therapy Designation for ARIKAYCE in the US in April 2014 based upon the culture conversion results in the phase 2 clinical trial.