Label expansion strategy(!!) in tomorrows investor presentation (INSMED website)
June is not that far away
eCTD will be filed in a couple of weeks and the CF Pa filing with EMA will be in 3-4 months.
CF Pa extension initial results.
They will be broadening delivery…podhaler?
Label expansion strategy.
“ Most resistance to aminoglycosides is caused by bacterial inactivation by intracellular enzymes. Because of structural differences, amikacin is not inactivated by the common enzymes that inactivate gentamicin and tobramycin. Therefore, a large proportion of the gram-negative aerobes that are resistant to gentamicin and tobramycin are sensitive to amikacin. In addition, with increased use of amikacin, a lower incidence of resistance has been observed compared with increased use of gentamicin and tobramycin.”
Commercial launch: 2015
# Field force 30 ppl for NTM
Q2: Continued dialogue with EMA and FDA regarding NTM regulatory path
Q2: First patient first visit in NTM open label study
File eCTD for CF Pseudomonas with EMA
Exact timing dependent on NTM data and EMA regulatory dialogue