To anyone smart, it did not do worse than TOBI. It was considered statistically equivalent and non inferior and you have to take it 1x a day, rather than 2x a day. The problem is that people were just expecting it to be way better than TOBI. Non the less, if it as just as effective than TOBI in only 1 dose, then in my book... that makes Arikase 2x as good. Problem is, now you have to compete in the market when your not considered THAT much better.
Arikace is a good drug, its nothing revolutionary but it is better. Thats why the stock barely dropped. Give it time and this will catch on when people realize this. I Sold my shares though and just took that 15% loss because I dont wanna wait... and I dont trust the idiots who dont realize that what I just said to help the price go up.
My understanding of a Phase III is that they break out the population along a number of different lines, including race, age, sex, blood type, weight, medical history and a number of others .. They were statistically comparable but I wonder if they performed better against certain types of people than others. I guess this will all come out when they publish their more in depth report.
terry, people are not stupid. The other drugs that have entered this space, like Cayston and Colobreathe did exactly the same thing...establish statistical non-inferiority to Tobi. Look at the data on INSM's latest investor presentation on the head-to-head between Cayston and Tobi. Tobi's % change in FEV1 was miserable, but Cayston's results were equally miserable after 3 cycles of treatment. Ergo, equivalence...ergo, approval. The CLEAR trial was a showcase of how Tobi can perform with enforced twice-a -day compliance and apparently lack of resistance to Tobi among most subjects. The big deal however, was that Arikace was not statistically inferior to Tobi after 3 cycles in FEV1 improvement, AND only requires once-a-day treatment, which is the huge plus according to docs and patients. NO DRUG has shown statistical superiority in any of these trials. Did you notice how Tobi's stairstep down in effectiveness was clearly in evidence in the CLEAR trial?