OK CoolBreeze, let me explain how I see the T-DM1 story.
Based on results from Emilia trial (2nd-line Her2+ mBC) Genentech has applied for and FDA has agreed to priority review of this data. Priority review expedites this process from a ten month event to six months, thus FDA will make a ruling by 26 Feb. Many believe it will be APPROVAL and the decision will be made even prior to this date, however not always is the outcome an approval, for example, FDA could requests further data to clarify sticking points.
With approval as likely outcome, ROCHE has been building up drug's supply to meet immediate demand. Reimbursement by patient of costs associated with treatment of agent by insurance is an other factor for further delay.
How approval will impact the current ongoing expanded access trial, i.e. will new patients be accepted etc. I don't know.
http://www.clinicaltrials.gov/ct2/sh...ansine&rank=16
Other T-DM1 trials will continue as planned and new phaseIIIs in earlier settings will be announced.
Threaded Mode