t315i

IMO a comment by Greg Collier in the 23 March release might be instructive. Namely that over the past several months ChemGenex has been working closely with the FDA on a diagnostic strategy to allow for the approval of OMAPRO.

To me this indicates 2 things. It looks like achieving an acceptable T315I test in not a new problem, to any party. Secondly, they would have been working hard to get the problem resolved well before the ODAC meeting, and failed. Lets say there were 3-4 months of negotiation/discussion without any resolution. So in this case it makes me wonder if proving/licencing/securing a diagnostic test is as easy as some might suggest.

Im aware of 2 off-the-shelf tests, one of which might be suitable for diagnostic testing as is. I believe CXS are not being as forthcoming on the history and details of this problem as they could be. Perhaps its just the companys style.