research report just published , page-13

Hi Golden

Cellmid's MK Elisa is a valuable asset and should anyone else produce one of similar or better performance (they can and in due course will) its use in clinical settings would fall under CDY's IP umbrella in most countries. From the newsletter of 30 July the relevant MK Elisa snippets are:

" Finally, we have completed the second batch of
GMP manufactured ELISA kits. We are not only
using these kits in-house, but selling them to the
research market in addition to utilising them as
collateral in our collaborations" ...... AND

" Our lab at the John Hunter Hospital in Newcastle
has been testing samples from a variety of patients
including COPD and kidney disease as well as in
colorectal cancer. They are also conducting
validation studies on our ELISA kit for plasma and
urine. This is important data which adds to our
regulatory package." ..... AND

" $37,000, which was largely the result of Advangen and web
based évolis sales in addition to receipts from our
ELISA kit sales." ....... AND

"Dr Erguven is using the MK ELISA to diagnose
polycystic ovary syndrome" ........ AND

" Our Kumamoto University project is progressing
well and we have now collected a progressive set
of 470 control samples, of which 230 have already
been tested (as previously announced) and the
remaining samples will be tested by the end of
2012. " ...... AND

" In addition to our out-licensing we have several
collaborations with clinical and research groups in
preparation for a regulatory meeting with the FDA."

Joining the dots I presumed correctly that regulatory meeting with the FDA relates to the MK Elisa and the use of midkine as a biomarker for cancer. Importantly, CDY is not approaching the FDA alone but collaboratively. If news like this arrived on the doorstep of any other biotech the share price would have moved IMHO.

The John Beveridge article sort of refers to the MK Elisa in the context of liver cancer ..... (I guess) because it there have been key writ ups abould this in top US medical journals.

The FDA will (I guess) be interested in the Kumamoto University results when they become available, reportedly at the end of the year.

I understand that Quest may have purchased some kits but there are other companies also exploring the use of midkine as a biomarker (eg Myriad RMB) so all I can say is the more the merrier.

That the MK Elisa will get clinical traction in the US is (in my uninformed opinion) a fait accompli becasue there are no altenatives (of the same calibre) that I know of.

On the issue of communication we have some new board members who are all quite capable of agreeing communication strategys and proof reading. I don't expect any further problems here. Also, Anton Uvaro (our RM Capital analyst) has both an undergrad degree and a PHD in biochemistry in addition to an MBA and so should be much more conversant with both the science and the likely business road map for CDY than I can ever hope to be.

Hope this helps but there are no guarantees associated with my dot joining.

Cheers