Member Info for johnlaycock

Hi All

I've had the following update from NICE and people's suspicions around the lack of news in the trading update on Monday on CYP2C19 roll out are unfortunately true:

NHSE have just this week provided NICE with the following update regarding the national commissioning decision for CYP2C19 testing:

'We are aware that a number of services are keen to understand national timelines for commissioning decisions regarding further rollout of CYP2C19 testing via NHS Genomic Medicine Service laboratories, prior to the use of clopidogrel following stroke in line with NICE guidance DG59.

NHS England confirmed that information from the pilot has informed the implementation of routine commissioning and setting out an approach to national testing for the future remains a priority. However, within the current financial year, it has not been possible to identify the necessary recurrent headroom in revenue budgets to support the funding of this testing for the indicated population.

This position is being kept under active review and takes into account the need to maintain all existing services for patients across the specialised commissioning portfolio, such as the delivery of all other routinely delivered genomic tests by the NHS Genomic Medicine Service.

We will follow up with relevant outcomes from the pilot and we will continue to keep our stakeholders informed as national work progresses'.

(the below is the NICE person speaking)

I believe the implementation guidance for clopidogrel use being developed by the CERSI will still progress and publish as will an implementation guide/pilot information document. So we are hoping there will be a repository of tools for those who may wish to implement sooner. I still dont have a publication date but I am hoping for mid-late September.

I am meeting with the NHSE team in mid September to update wording on the NICE website and hope at that point to have an update re publication of the CERSI guidance and implementation guide.

Yes Roger. It's in the RNS that they are assessing a broad range of finance options. Did you miss that bit?

To clarify for the umpteenth time . Friday this week is when final comments from stakeholders (such as GDR) are due to NHSE on the implementation plan roll out . NICE have stated that the plan will then be released shortly afterwards. Keep an eye on the NICE website.

Clearly a difficult update on the cash position but...

- the Chair is incredibly well connected in this field. He won't let it go belly up and you can be sure he is central to the funding solution

- the RNS stated the board has a number of funding options. I don't think further dilution is one of them

- in the next few days we should know the outcome of the CYP2C19 pilot findings and the NHSE plan for a national roll out. This should mean a huge revenue increase for the company over the next few months

- they have stated they will be EBITDA positive by next June at the latest. Nothing in the RNS contradicted this so they must be very confident of revenue of at least 500k per month soon

- international sales are clearly progressing and more concrete news on this is due soon

But the short term funding clearly needs to be sorted soon .

If it's non dilutitive, then the SP will rocket.

I don't believe the facts support your argument Roger. Would a company fearing they are about to run out of funds consistently post social media stories on events they are attending/ sponsoring in the future create a new website and advertise for new staff?

You can guarantee Gino Miele will know exactly what's in the implementation plan and will be busily preparing for a huge increase in demand for the companies CYP2C19 test.

Hi Roger. If you look at my postings you will see I've always been consistent saying that the implementation plan will be published shortly after August 15th which is the exact language NICE communicated to me. So no delays from what has previously been stated on this chat..

Next Fri 15th is the final day for any stakeholder comments on the NICE implementation roll out guidance . The plan should be then made public shortly afterwards. NICE will update the information to their Web page as soon as a date is confirmed for publication.

I suspect the website redesign is to coincidence with the imminent publication of the implementation guidelines for the CYP2C19 national roll out.

It should be taken in the context of them also advertising for new staff.

That will reduce the cash burn then!

New test centre added (Rhyl, North Wales)

https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=56066

If you think we're going bust (which we are not) why on earth are you still a shareholder?

Thanks Jimi. All NICE have told me is that the implementation guidance should published shortly after 15th August. Comment from those involved is open until the 15th so the guide should happen quickly after that. I am now trying to find out about the pilot findings.

Given we can now expect the implementation guidance shortly after Aug 15, would it be safe to assume the pilot findings will be published sometime before then? I think that will give us a big clue into what will be in the final guidance.

I contacted NICE who confirmed the 15th Aug date. Should see a steady sp rise then over next few weeks.

I've had it confirmed from NICE today that the CYP2C19 Implementation guidance will be published on or shortly after 15th August . Hopefully the pilot study findings will be published soon too which should give a good indication of what might be in the Implementation guidance.

So not long (4 weeks) until the transformational news lands!

The pilot study and implementation guidelines for a national roll out is due anytime now. The actual roll out will then commence within weeks.

Interesting!

https://www.linkedin.com/posts/activity-7351508176027963392--FxE?utm_source=share&utm_medium=member_android&rcm=ACoAAAAMhbsB_NgSe9dupPlFVCvI337zRJ75xs8

Delay would assume a previous announced timescale hasn't been met. No one has said the implementation guidance would be published by a certain date.