Understanding The International Conference on Harmony. Europe, Japan, US etc -cross filings- rehdvm2004
I stated a fact about Insmeds position regarding a US filing (and have corrected your "possibilities" in the past- when you said Insmed could " possibly have 2 drugs on the market by 2013)
I am aware of the 1993 conference... how many drugs has the FDA approved "in harmony" in those 20+ years?
Please accept the fact that Insmed has at no time suggested they are planning a NDA for CF.
If something changes, rational investors will accept the information.
"Please accept the fact that Insmed has at no time suggested they are planning a NDA for CF."
You're getting confused again - CF is a disease.
Insmed is planning a NDA for ARIKACE - supported by the totality of the data from the CF and NTM clinical trials, the Expanded Access Program and the Non-CF Bronchiectasis study.
The FDA has been approving drugs on the basis of data from adequately-designed foreign clinical trials for years.
The legislation enacted last year to accelerate the availability of drugs to combat the threat of pathogens which have evolved resistance to drugs currently used to treat infectious diseases provides an additional incentive for early approval of drugs such as Arikace, which deliver broad-spectrum antibiotics such as amikacin.