In case Arikace is indeed on sale in Canada before the accelerated approval process makes it available in the US, kindly elaborate upon this observation -
"A US doctor writing a expensive script for a Canadian pharmacy would have a lawsuit on his hands quicker than you can say podhaler."
1. Specifically, who are you suggesting would sue a US doctor for prescribing a drug available in Canada to address a serious medical need for which no drug available in the US is effective for any longer than a month or two?
2. Have you ever considered engaging your brain before your mouth -
[ If you choose to purchase Canadian prescription drugs by traveling to a Canadian pharmacy on your own, remember:
While importing Canadian drugs is against U.S. policy, the FDA has said that it will not prosecute individuals who import small (3 months or less) amounts for personal use.
The drugs you purchase may or may not be approved by the FDA, which is a U.S. regulatory agency. Canadian pharmacies sell drugs approved by Health Canada, which has standards that are similar to those of the FDA, so you can be reasonably assured of safety.
You may receive a generic substitute.
Work with a health care provider who is familiar with writing prescriptions in Canada
The Canadian pharmacy may be overwhelmed by U.S. customers, so be sure to check your medication, dosage and instructions carefully before you go back home. ]
In case Arikace becomes available in Canada before the accelerated approval process makes it available in the US - it's worth noting that a 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off-label.
30,000 in the US with Cystic Fibrosis plus 50,000 treated for pulmonary NTM each year would generate substantial off-label use.
The Victoza adoption curve never gets old. The only significant driver with Victoza was the convenience of once-daily vs twice-daily.
Add to that the promise of the first ever antibiotic proven to halt the relentless deterioration in lung function in Cystic Fibrosis for a year (and counting) instead of a month or two, and we're very likely to see something which makes this look tame -
Assuming by Week 30 patients were collecting a 30-day supply, by Week 33 the convenience of once-daily dosing instead of twice-daily had already attracted 64,775 patients. Thirty months after the launch roughly 160,000 patients were using the new drug.