a lot of best case scenarios by Will. It'll never happen in less than 2 years on anything, even a restricted label should the FDA let all the "compelling data" sway them for CF.
Insmed is completely blinded to the data.
Risk up this morning guaranteed.
Will is quickly developing a Mojo,and reality should be seen with this call.
Bravo , Will
That really depends upon who the new regulatory person is. Remember, it used to be LaBella (a MS crony who was a device person who had no regulatory drug experience). No wonder he could not explain two rats with foamy macrophages! But remember also that the NTM study is Co-Sponsored by NIH. NIH has one of the top clinicians in Dr. KN Olivier AND they have their own QA and clinical case monitoring system. They will be the medical and regulatoy people across the table from the FDA at the NTM data review. INSM will be there largely as observers and to bring in any data that may apply from the CF/Pa trial (that is if INSM does not bring in Chiltren). I think that WL has cleaned house more than what is indicated. The INSM head count is down from 44-45 to 41 on Yahoo. Not sure that is anything but focusing all administration and R&D dollars on progress. But I see entry in late 2014 based upon "compelling data" as a real possibility. But I am basing that on near-term past performance and a restructured management team.
Nice thread.The meeting will not be public and will take a considerable time.
The President is taking the best possible outcome.Government agencies have their own clock.
late 2015 if they have the data.2018 if they do not.
WL "kept his powder dry" for the total summary in the 10K. There he will bring closure to lots of data that many posters (including me) would have created little pops in SP along the way. But true Longs on this stock who have been invested for years and want the SP to climb and hold SP keep getting blindsided by the people and groups manipulating this stock. That is where the pumpers and shorts come in.
But the 10 K will most likely be a clearifying statement for (in increasing order of priority of interest, but not order of presentation):
1. What those nanoscientists might be considering as possible categories of therapeutic in the future (this information might be a key to INSM partnering to develop totally novel therapeutics in the future).
2. Some sort of summary of the dog study and why INSM submitted the data directly to the FDA. The FDA should also have come to some sort of preliminary conclusion that might be worth sharing also.
3. The value of the $11.5 in the scheme of INSMs future.
4. The status of the Chiltren QA audit of the CF/Pa data.
5. The status of enrollment in the Extension Trial (hopefully 80% are continuing because that study only anticipated 50 of 300 to drop out).
6. Most importantly where is the enrollment in the NTM study.
7. Future, more specific regulatory plans based upon 4, 5 and 6.
This is a slow, stepwise process towards regulatory approval. It is also a pan-global effort.
We shall see on May 23. Not that far away.
PS - if a poster is anti-hype, does that make them a basher?!? Let's ask a pumper.