The key will be how difficult it is for Bristol Myers Squibb to ramp up a production line and set up distribution channels. BMS' dasatinib (nickname Sprycel) will be reviewed on June 2nd by an FDA commitee. The FDA notice is at the following link: http://www.fda.gov/ohrms/dockets/98fr/E6-5413.pdf (it is the second notice on page one)
If the results are positive (we have heard that they are), and there have been no issues discovered regarding toxicity, major side effects, or other negative issues, the committee should recommend approval to the full FDA. That full FDA approval could take several weeks after the committee report, so full approval may come by late June. If it is approved, it then depends on how long it takes to start a production line for dasatinib-Sprycel. Most drug companies do not set up a full production line until a drug is approved, but if they feel lucky, they might have done a lot of work already. I would not expect to see the first pills available in June. Maybe July, but probably August is more realistic. Also, here is an excellent summary of the drug pipeline for CML and other cancers that focus on kinase inhibition: http://www.pharmaweek.com/FlashReport/MultiTarget%20Kinase.asp --Trey --~--~---------~--~----~------------~-------~--~----~ [CMLHope] A support group of http://cmlhope.com ------------------------------------------------- You received this message because you are subscribed to the Google Groups "CMLHope" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [EMAIL PROTECTED] For more options, visit this group at http://groups.google.com/group/CMLHope -~----------~----~----~----~------~----~------~--~---
