After being buried in a consulting job that lasted several months I finally finished this a.m. and can once again pay some attention to this crazy MB. While Bugsey nailed it yesterday by diagnosing terry with NPD, I believe that Insmed is moving closer daily to debunking his most oft used scare tactic - that Insmed has virtually given up on CF here in the states since a costly phase III trial would be required.
IMO there will be a costly trial, but not for cystic fibrosis. The next phase III that Insmed will conduct here in the states will be for non CF Bronchiectasis. That market is far larger than the CF market, and Insmed already has stellar phase II results. Since the same doctors that treat Non CF Bronchiectasis also treat CF patients a positive trial would open a whole new market, while at the same time contributing to far more off label sales. Very positive results, along with the European data, and QIDP designation for NTM, may indeed open up a discussion with the FDA regarding filing an application for CF licensing here in the states.
Terry also likes to warn us that Insmed may yet have to file for a phase III for NTM in order to ever gain approval. That makes no sense. If the current results are good enough to enter a phase III, they will be good enough to get approved. NTM is growing 8% a year and has become a very costly disease with no approved treatments. The FDA had originally allowed Insmed to enter right into a phase III but backed off after the rat results. With that no longer an issue,, the current NTM phase II trial remains a phase III in disguise.
What has been moving the shares recently with seemingly no near term catalysts. Well, my guess is that there is a very near term catalyst.