To address the questions above from 'lizbeth and grace:
The FDA refused to file the fast track application on the grounds that the study did not meet the standard of filling an "unmet need" because it was a single-arm study (no control group) and the study population had not exhausted all available treatment options, regardless of Her2 status. So the FDA would not file the request for accelerated approval.
Obviously, we on this forum see it differently.
So the additional 2 year "wait" is the normal timing of the Phase III registrational trial EMELIA.
Several individuals, myself included, have been working on responses, making contacts etc but given that the group itself is somewhat in a state of transition following Joe's passing we have not yet responded formally as a group.
I have been in contact with Danielle (Christine and Joe's daughter) about having a page on this site on which we can discuss this topic, provide direction and support to those who wish to send letters etc. I've been collecting and researching content for it and this will be in the works. I hope we can also create a position paper and formal letters in Her2support's name - but have not yet cleared this with Christine.
In the meantime, there is much information on the thread "what can we do about the delay of TDM1" (see link below), including guidance on who at the FDA to contact as well as "how to contact your congressional representatives". Maybe especially any newbies who may have blank todo lists on Nov. 3.
I have been told that that is the most impactful way to be heard - lots of letters.
IF YOU HAVE THE ability (and there is a lot of info to use in the thread below), to write your own letter please do so now. While it is important to be factually correct, your input as a her2+ patient waiting for access is important in its own right. As a Her2+ survivor you have every right to make your voice heard so feel free to speak up - firmly but appropriately. You can add your voice to any group efforts later, too!
You don't have to write a new War and Peace - or wait for anyone else.
There is some more current discussion on this thread:
http://her2support.org/vbulletin/sho...ht=tdm1&page=4