http://seekingalpha.com/article/1878...nscript?page=8

"Carlos V. Paya M.D., Ph.D.

Annie, this is Carlos. Thank you for the questions. The three sub questions, the assay — there are a number of steps that are very clearly outlined to regulatory pathways so the assays can become commercially available. One of them is to gather additional information because as I mentioned, the data that we have as to how this assay was generated was using source samples that had been prospectively collected, but that was not the whole purpose of those collections. So we really need to now do a very thorough evaluation using prospectively collected sample studies where we are going to study in the upcoming months trying to validate two things.

One is the sensitivity and the specificity of this test by comparing serologies we saw with viruria using PTR. That’s one of the ways to validate test. The other one is to then – once you have a test validated is that seropositivity always precedes or concurs with the presence of PML. I recall that already with the PML cases we have, we did have 11 cases where we had samples drawn ,and those 11 cases were already positive. Our goal with these additional studies is to now confirm those findings, which will then bring the reassurance for everyone that it can clinically predict the PML appearance. With those two packages then, that is what you proceed forward with regulatory path for approval to become a commercial test.

In the meantime physician incorporating and signing up with these studies will have the chance to be running the test in their patient samples. And therefore have the ability to understand more results coming out to them. "

http://seekingalpha.com/article/1878...nscript?page=9

"Carlos V. Paya M.D., Ph.D.

I’ll take a number of questions there. Maybe Shane can help us with the profitable numbers in the US. So with regards to the exact timing, I cannot provide any guidance right now. We are in the midst of discussions with both regulators in the US and Europe. So we can have additional strategy after this discussions after the – kind of narrowing down the timing. But right now our objective is to as quickly as possible, roll out these two separate studies. Again, one to validate the (inaudible) in perspective samples. And two, by the clinical reliability to predict PML. Those data need to be available, I think, for a robust package for rapid approval. (Inaudible) discussions we’re having with the regulators. "