The 'world record', so to speak, for preparing an NDA is abt. 10 weeks after the close of the phase III trial. Anything less than 15-20 weeks is outstanding. So, expect at least 3-4 months after the close of the final phase III trial before the NDA is submitted.
Reviews at the FDA are getting faster, but still average somewhere around 18 months. Generally, the only drugs that gain approval in less than 1 year are the AIDS drugs.
Once the drug is approved, expect 2-3 months before launch. The company has to fully scale-up manufacturing, get the sales force trained and prepared, and product has to be shipped to pharmacies and hospitals. That takes time. Of course, the company will do as much as it can ahead of time, but to justify it they need the periodic updates from the FDA that suggest the product will be approved (such as the number of questions the FDA asks, the voting of the FDA Advisory Committee, etc.
All told, I wouldn't expect dollars to be earned for abt. 2 yrs following completion of the phase III trials.
-Mark |
