Where to from here?, page-56

As far as I am aware, they were near to completion of analysing Janssen’s trial data from CREDENCE study.

A companion diagnostic requires proof that it matches well with a drug & can assist in identifying patients that it will be of benefit to. I think that this is potentially what we are waiting on, and as we are well aware, these things take time (validation). We have that for the IVD, but the Janssen data, IMO is for a CDx.

As the CKD/CVD indication is very new for Invokana, I am guessing they may be going through process of applying for a CDx status with the FDA. From what I have read, the FDA do not hold up CDx’s when the drug is already approved for use in that indication.

I could be completely wrong here, & it has been a question in my mind recently, so I think on this one, I will drop Richard an email & ask. I will also go back & find that link for the information on the FDA approval process for CDx. I don’t like to bother people, but I think the question is a valid one.

I did post a link recently for another CDx (as an example) that came out of a collaboration with Janssen, and this is available through Labcorp, a Tier 1 diagnostic in the US, that is set up well with health insurance companies. This is a CDx for patients with urinary tract cancer, I think that CKD in diabetes (possibly also CVD) is going to be far more “mainstream”.

I guess that many factors have to match up, including that Health Insurance companies are happy to cover the cost of PromarkerD test through labs in the USA under their healthcare system, and Richard has indicated in earlier ASX ANNs that there was keen interest there, as it will save them millions, if not billions of healthcare dollars on ESKD treatment (dialysis & kidney transplant).

Anyway, those are my thoughts & IMO. I will let you know on any reply on email. It’s most likely a price sensitive question that I have, so the company may not be able to divulge that information, but you can often read between the lines.

GLTAH

Ps. @Aruc I find the SP a bit frustrating too & I wonder why?? I would rather a deal on a “fully baked” pie though.