Member Info for bighammer

COME ON ENGLAND.

System, i thought you were always drugged up . LOL. All the best for the op mate and hope its not too serious and look forward to your posts later on this week.

They can apply for funding for the cost of data recording etc not so sure on the cost of tests?.Nice want data also from maternity wards and not just neo natal so any hospitals will do so to speak , and different regions which is why i thought overseas would be great. It is clear to me that NICE are doing as much as they can to get AIHL up and running but with the caution of more detail is required.

I would rather have seen a specific number rather than timelines as you could have 1000 in 3 years or 2000 in 12 months , we can only wait and see.

NICE want data on the tests carried out , and as we could potentially get sales outside of the UK then they should/could/would be included . Whether NICE would is a totally different matter, no stipulation has been made of how many hospitals need to be in the data , or where. ?

Eureka01, a very good post outlining other ways in which we can sell AIHL . Nice have clearly stated they will revue in 3 years time on results gathered, now is that timeframe based purely on expected sales in the UK? , what if we sell to other countries i am assuming we could /will then they would surely be added as it is ticking many of their boxes being different ethnicities and not top neo natel hospitals. As stated we can apply for funding to help collate all the data from the office of Life Science .

What we do need is sales , not just from the UK but also from Europe etc , millions of orders are not needed ,just orders to show the market that it has the ability to sell then positivity will come back .

At no point have NICE hinted that the test is just ok , we have a conditional RECCOMENDATION and 4 points that they would like more clarification on. So far from memory 6 infants have had their hearing saved from this tet, just in Manchester , how long will it be before other hospitals are in contact to find out how good /easy it really is before finding the money to invest in the machines and tests, all in my opinion of course.

Joe, until we hear anything from the bod , everything has been discussed to death and opinions are all there is .

Further evidence generation is recommended on:

how the test affects time to antibiotics in smaller, non-specialist centres and outside of neonatal intensive care units

how the test result affects antibiotic prescribing decisions

the failure rate of the test

the diagnostic accuracy of the test.

And these are the 4 things they need more info on for full approval, the last 2 are almost the same question, the first one is an insult to the nurses etc who are carrying out the tests and diagnosis and you could even say the second one is linked to the first ?.

NICE's role

4.4 NICE's role around evidence generation for digital health and medical technologies will be to:

Identify what additional evidence is needed for NICE to support using the technology in the NHS.

Work with the technology developer to:

identify system partners who may be able to support the design and delivery of an evidence generation plan, and to broker relationships, as needed, with potential data controllers and research funders.

identify and engage with experts who can provide advice around evidence generation.

determine what should be included in an evidence generation plan, including guidance on suitable approaches to generating the evidence.

develop a proportionate and pragmatic approach to evidence generation with consideration for the burden on patients, healthcare professionals and the wider system.

help the development of evidence generation plans through multi-stakeholder engagements.

Share the published final evidence generation plan with stakeholders.

Link technology developers with potential research funding partners.

Technology developer's role

4.5 The technology developer's role will be to:

Support evidence reviews to identify the most relevant evidence and information relating to the decision question defined in the scope.

Engage with relevant stakeholders to help develop and implement an evidence generation plan, to:

Identify robust approaches to evidence generation, consider aspects such as study design, data quality and suitability.

Work with potential evidence sources

This what NICE should be doing along with GDR but so far heard nothing.

We are assuming NICE have informed them , if that is the case then that surely is price sensitive ie RNS worthy?.

If it was just about revenues for GDR then we would be wasting our time even trying to sell in the UK as even when fully rolled out the projected income is about £5m which would be just about enough to keep the lights on. AIHL is about world wide sales not just the UK ,BUT and this is the big one, we need NICE reccomendation. I was on the thinking that even though we had conditions attatched we would still get sales and it now seems those thoughts were wrong , what we dont know is how much more info they require before we get the green light, it could be 1000 tests 10000 tests or even more . It would be good if the bod gave them a nudge to find out their exact requirements as they were supposed to be working with the company as well.

Any full NICE approval on either test will be huge imo, i am realistic enough now to realise time is needed but optomistic that these are tests not drugs so a less stringent tests will be applied . If i did nt think would come good then it would be pointless staying,how long it will be is anyoness guess but not as long as some think , HOPEFULLY.

Roger, do you really think that because 1 company will take up the entire market and there wont be room for a bit of competition , REALLY????.

I dont think anyone expected we would be the only one and the best with either of our tests and that Genomadix is out there now means more lives will be saved but exactly how far are we behind them, who knows ?. Our figures and timelines are about the same but more trials will be needed but comparisons can now be made which will help for any market not just the US .

As for AIHL , We know we are starting to meet NICE conditions. going on the latest news, more tests are being carried out numbers wise so that will hopefully give credence to its accuracy and working on the sublimely obvious it is being used on a number of different ethnicities as Manchester is not a 1 race city. The one condition that i found a little odd was the testss rolled out to non neo natel wards, implying the training would be different and the midwives/nurses were less competent elsewhere, really. The big question is how many more test will be needed before we get full approval , for me this will be based on number and not timelines , i will wait and see when and if they publish the requred data they said they would.

Bank, i take it you have bought back in ????/

Afternoon System , not seen anything yet that has changed my mind, but then again not seen ANYTHING for a while. It is taking longer than i first thought but nothing to suggest it wont . I am still waiting to see what NICE actually want so that will be interesting as and when we get informed?.

No he is not, just the original one lol keep it upSystem.

Starrs, you could be right , i just seems strange that the NHS is pushing genetic testing and the govt is funding it as they seem to think it will be cheaper in the end to then stall when it is readily available not just the 2 specific tests we have but in a way a gateway on how to develop the testing process???. NICE have agreed in principal but have not yet specified exactly how much more information they want which is something they impied they would in conjunction with GDR, once we know that then we will have a better understanding on how long it will take and how much funding will be required.

I agree with Brighty that the big numbers we are looking for and which are possible are a long way off and the market are making it very clear that only sales will re rate the sp in a big way . The genetic market is going to be huge imo over the coming years and we have a foot on the ladder , we dont need to be the market leader to make a big difference just being on the playing field will surfice.

Morning Ben, you are so right . I have moved over to that side now got an offer too good to turn down . Tke pro snaggers have digested NHBC tolerances to the mm and walking round with laser levels checking everything along with drones overhead. Contractors are taking the hit for now but how long before they start passing on some or all of the cost to the tradesman , when and if that happens say goodbye to the housing industry as we know it.

Its all in the wording i feel , to try and prevent a sunday battle of words , its in the UK and not across. As much as i would like it to be all over the UK so far it is just Manchester from what we know.

The one thing i am not sure on is timescale, until we get more clarification from NICE we can only guess, it could 2 years it could be 12 months this is the uncertainty for me .