RE:USA/CHINA4 May 2023 23:41
Evening all.
thanks for the vote of confidence Vincent Vega.
My opinion on the time taking for optimization is as follows:
i believe optimization is complete (that doesn't require RNS just yet as it doesn't constitute a financially material event) However, there is more to the process as just the optimization stage. Following optimization, as a new device, requires Validation, and then Standardization.
If you read a cited open access paper DOI.10.5772/intechopen .94338 this gives you the stages, and explanation of what we need to do. My thoughts are that we are in these stages. This view is supported somewhat by Allan Syms comments recently in RNS ...
"The current research programme has MET some critical milestones especially in optimizing the platform and antibodies....."
"....builds on SUCCESSFUL OUTCOMES of current research programme for monoclonal antibodies and platform optimization"
The reagents/antibodies are common to both the China project, and the US project. However, we do already know that we have engaged other manufacturers (CRO's) to develop further variants of the CIZ1B platform in order to increase our range of cancer detection. We are building a library of reagents/antibodies.
I have recently read a paper on the various Exon splices (CIZ1_F, CIZ1-S etc) that have been shown to be a good identifier of breast cancer and colon cancers, so that may also be a reason that optimization is seeming to be a long drawn out process.
LB yes, the holy grail here is to ultimately develop the test to be a lateral flow type which is what the BOD have in their minds. But as you note, this is only one aspect of what is possible. Mention has been made on more than one occasion that we are developing into the therapeutic side of cancer as well as diagnostic. - another huge opportunity.
I have seen the new posters "what news is due" and placing comments.........come on, do a bit of research, or at the very least spend some time reading up on previous posts please!
Placing? we are funded well into 2024, even without the prospective £3.25 million from the put option, the additional £500,000 finance option, £200,000 on commencement of the companion diagnostic test , up to £1 million in fees for the same, and up to £5 million in royalty payments. That is before any proceeds from the supply of the reagents and antibodies to China and USA, not to mention the royalty payments from those too when we commercialize!!!
Note.... previous communications from the company always stated developing the test for "CE and/or FDA 510 (k) clearance. Anybody noticed that they now say UKCA, CE marking, LDT and/or FDA 510 (k) ? A subtle difference, but very important. NHS here we come......
Now you may laugh at this one, but did you know that the market for Vetinary oncology is currently $364 million and predicted to grow 8% per year?
Neil