Member Info for JimiHendrix

Same here Roger! ...I've bought a large amount over the past few weeks thinking that they'll probably drawdown from RF, being that they could do so at minimal dilution (assuming RF agreed). Haven't gone in full though as I knew it was risky and they could do what they have just done at any time. It's odd that they're doing it now rather than when the shareprice is higher.

Hopefully most will chose to take part in the open offer rather than buying in the market, so at least they'll be very well funded.

There is still upside from the current level over the coming months, I haven't calculated it yet but I expect considering the dilution, 10p will equate to about 50m mcap which it should breach after July NICE news.

A drawdown from RF would be the least harmful funding method in the near time I think as the shares are issued at around 10% discount (from memory) which is not a huge amount of dilution compared to most traditional discounted placings. So I think the best method is to use RF to keep them going until after the July NICE news before doing a larger placing.

The thing is, if they decide to do a Riverfort drawdown and the longer time goes by the more likely it seems, then it suggests to me they may well wait until after upcoming positive news before doing a fundraise.

Roger, AIHL test I believe for 2027 (FDA approval expected then).

Not sure if we’ll get an update regarding the consultation as I don’t think we did for the first one or with AIHL’s consultations but let’s see.

In the presentation JC said that the required planned funding was one of the things the FDA partner deal was waiting on before it could be signed off. The news today makes me think fundraising has probably now been agreed, let’s see if a placing is announced in the next few days.

Some huge buys went through earlier. If there is an announcement on Friday or next week regarding stroke test this really will move up...

If there's anything I would expect it next week after the consultation closes. The consultation comments will be revealing I think. Even if the final decision is not published until July we may get an inclination from the comments after Friday.

Yes full recommendation coming, and crucially lab testing simply isn't going to be able to handle the number of tests required. There is nowhere near enough capacity for lab testing, so that's where the Genedrive test will shine. Additionally lab testing simply isn't fast enough in many instances, so again, the Genedrive test will be the best option.

Roger, regarding "final say"...

NHS have 3 months to allocate funding...

"Funding technology appraisal guidance

The Secretary of State has directed that the NHS is required to provide funding and resources for medicines and treatments recommended by NICE through its technology appraisals work programme. It normally has three months from the date of publication of each technology appraisal guidance to provide funding and resources.

Where it is not possible to acquire the technology or where, perhaps because insufficient trained staff are available, the intervention cannot be applied within the three month period, it can be extended. Extensions are granted by the Secretary of State, on advice from NICE.

The three month funding Direction has been waived or extended for about ten percent of the technology appraisals issued to date. They include surgery to aid weight reduction for people with morbid obesity, home compared with hospital haemodialysis for patients with end-stage renal failure, patienteducation models for diabetes, continuous subcutaneous insulin infusion for diabetes (insulin pumps) and photodynamic therapy for age-related macular degeneration."

The Genedrive POC test is to be used when lab testing isn't available (currently lab testing capacity too low) and in some cases not quick enough.

The Mantara lab test uses a lab in Germany. It's highly unlikely they pose any threat to the Genedrive test for NHS use.

Roger, fear not! The Mantara test is not a POC test, it is not a direct competitor.

If there are currently talks going on around taking it private JC would not have been able to disclose anything. His reaction was more informal, at first he seemed like he wanted to explore the question but then decided he'd rather not discuss anything. This suggests there is no current plan to take it private but perhaps it's something they may consider in the future ...or the long term plan may be to sell the company off to a private buyer (when the company is worth a lot more.)

Is it possible that NICE could announce the full recommendation decision on the 26th April (or following Monday) at the end of the public consultation period, ahead of the formal guidance publication in July?

It is the recommended ‘POC’ test, only when lab testing isn’t available, lab testing is the preferred test and first choice for several reasons. It will be very interesting to hear hopefully in July how they decide to roll out testing.

Everything is in this document…

https://www.nice.org.uk/guidance/gid-dg10054/documents/consultation-comments-and-responses-2

Just to point out we don’t have £1.5m cash in the bank, it’s less than £1m now. We do though have access to the Riverfort facility from which we can draw down £1.5m in exchange for new shares. That is something management are not keen on doing though, they’d prefer a traditional placing.

I’m suggesting it’s not clear how big the market will be for the POC test, particularly so because lab testing is the preferred choice and adoption of POC tests is determined on a local authority basis rather than a single nationwide decision.

IMO it will depend on how quickly lab testing capacity is ramped up. There was a bit also in the guidance about potentially rolling out lab testing gradually as to not overload the current infrastructure. So some areas would get it before others.

What I was hoping for is mandatory national adoption of stroke marker testing from July, and a lack of infrastructure meaning our POC test would be used extensively until lab testing was able to cope. But it doesn’t sound as though that’s how it’ll be.

“ A benefit of laboratory-based testing is that in England this is commissioned nationally via the Genomic Medicine Service and delivered through the NHS Genomic Laboratory Hubs. This provides an opportunity to ensure better equity of access to testing when compared to POCT which is likely to need funding and implementation at a local level.

…

Thank you for your comments which the committee considered. Several stakeholders and experts commented that centralised testing would reduce variability in testing offered across the NHS. Experts raised concerns that if left to local centres to implement testing with point-ofcare tests, this would likely lead to considerable variation and could worsen health inequalities. Some committee members said that existing infrastructure should be preferentially used over investing in new single purpose technologies. The committee concluded that laboratorybased tested was its preferred method to implement testing. These considerations are in section 3.16 of the updated guidance. ”

He said the guidance suggests the test has to be done in 24 hours. It doesn’t explicitly state that from what I’ve read.

The modelling was based on Clopidogrel usually being given 24-48 hours after minor stroke. Lab testing has the potential to provide test results in 24 hours but currently there are delays in some labs. Basically infrastructure not there yet I think.

Https://genomadix.com/genomadix-announces-fda-clearance-to-market-the-genomadix-cube-cyp2c19-system-2/

The Genomadix Cube has FDA clearance, European CE-IVD already and UK clearance, so it would be interesting to see how much of the market they are currently taking.

The Genedrive test is better so the hope is we will sway their customers over to us once we have CE-IVD next year and when their contracts are coming up for renewal and sign up those who aren’t using anything yet.

I would also like to know what the current lab capacity is (well from July / Aug) as the shortfall may indicate the actual POC market in the UK for stroke marker testing.