I'm not super up on the formalities of trials but...seems like other drugs have been given fast track, orphan status etc. Eg.
http://www.medicalnewstoday.com/articles/58460.php
Is that not possible with a drug as promising as TDM-1?
That having been said are PARP inhibitor (BSI-201) trials nearby?
Also, how about
:
http://www.mskcc.org/mskcc/html/2270.cfm?IRBNO=07-155