The objective of the new legislation is to "encourage" the FDA to expedite the availability of drugs where there is data "reasonably likely to predict clinical benefit" in "unmet medical needs for serious or life-threatening diseases or conditions".
The most effective drugs currently available to the NTM patient population require the patient to endure serious side-effects for a minimum recommended period of two years.
The most effective drugs currently available to the CF patient population are only able to halt deterioration in lung function for a month or two.
The FDA will have data showing that Arikace halted the deterioration in lung function in CF patients for a year (and counting).
What reason could the FDA have to refuse to use its new powers to make Arikace available to the US CF patient population?
Hopefully the data from the NTM study will be considered by the FDA "reasonably likely" to predict a clinical benefit in a second unmet medical need.
The odd thing FUD is, though all the facts we have all read support what you have been posting, the market feels very uncertain about Insmed ever since mid to late January. For example, I thought today there would be a "rush" to hold positions over the weekend which subsequently should drive us back into the $19,s. But we are not seeing that (at least through my eyes) so far. Very confusing despite the pending news in 5-6 trading days.
aswpe post .No one knows.Uncertain ? 2015-2017+ On Insmed site. but pumpers here pump tomorrow.If Insmed SAYS 2017+ NEXT WEEK FOR non turb and a phase lll for cystic fibrosis. no rev for 2-4 years and the company will need a ton of cash.And you ask why uncertain? Forget these pumperaswpes. Risk is high for a delay in the time to deliver their products.