Member Info for bighammer

A good steady day hopefully more to come , gutted in a way as i have some cash coming free on Thursday looks like i may have to pay a little more than i was hoping.

Steady rise to 30p then NICE news stating confirmed acceptance in 2 months time following further research, with 50% rise ,a few days later fund raising regarding 20% discount . The following week RNS released with FDA application down the De Novo route with news due in September . In April the stroke test is launched and we start to get trickles of steady sales , where would the sp end up , IF ONLY .

Lloyd thats how i feel so if he can do it with a higher sp then that will lead to reduced dilution and if he can do it also with news in his back pocket to let slip to IIs then he can reduce the discount given . Illegal you al shout , yes and that is how it works , the consultation period must surely be over with FDA on pre submission so it is possible they know what route they could go down , with NICE approval it looks likely De Novo is possible $100000 costs ish and 5 months for results BUT they only have to issue an RNS when they apply for the route taken and if they do this a week or so after dilution of say 15-20% then the II s get there money back with profit and have less dilution , everybody wins in the long run .

Lloyd there are any number of possibles this will pan out but i think and expect them all to lead to a positive movement in the sp over the next 2-3 months , unless you are looking to trade your existing holding then it is just sit back and relax. I can see this slipping a little to 14 or 15 over the next few days and then see a steady climb well into the twenties leading up to the start of the NICE review with traders looking to sell pre RNS as they will be very happy taking anything from 20-50% profit as many will sell before news .

Hodjie . it seems to depend on what site you work on it seems and what region and site location . The big problem at the minute is not recession mortgage rate or anything else , its the weather , no bricklayers laying , plasterers struggling leads to a knock on effect for others . We have a few sites where chippies cant get a full week in as we have now caught up with the brickies but sales seem to be ticking over steadily so far on some sites and with sp holding up quite well it all bodes well for the rest of the year imo.

Afternoon Lloyd , I personally would like to wait awhile . Firstly the higher the sp the less dilution we would have to do so as to have a better bang for our shares and the other reason is the longer we wait the better idea we would have so the less dilution we would need so it would be a win win on both fronts . I can see the thoughts of just getting it out of the way so we can just plough on but holding off for a couple of more months may well benefit us all in the long run.

Similar to AIHL, it uses our capabilities, chemistry and hardware to rapidly produce a result at an emergency care bedside. By analysing the genes of a patient's drug metabolic pathway, certain poor drug options can be removed from the treatment regimen of each individual patient, with the aim of providing reduced incidence of subsequent strokes

This is the jewel in the crown , the technology . There are 3 stages to NICE , and if we get no1 that is the green light for the NHS and sales and FDA application and approval , and as it is already up and running in NHS hospitals how long would it be before they give full reccomendation ?. Continued sales will get takeover offers but the technology will add considerably to the final price imo.

The good thing about this timeline of study is it now gives us a more accurate date of when to expect an rns . i am going for approx 2-3 days after the 17th when it is concluded , add to that the fact we have a test that is needed and with proffesional healthcare approval then reccomendation should be straightforward , 4 weeks and counting.

A good solid week and even better today as i was expecting a 10% ish drop with the gains made this week . If we can hold above 14p ish until the end of the month then it will set us up for a pivitol 3 months ahead . With news due in February from NICE and stroke test to be launched in March /April and then somewhere in between we should get an update regarding FDA application there is a lot to be positive and look forward to . Yes the company did say they would need to raise funds to take us into 2024 but this was before they knew what route we could apply to the FDA and were quoting £2m costs which is looking to be a lot cheaper and how quickly NICE were going to act . We have seen how quickly the sp can move sadly in both directions but going on some of the regulars averages many will be very happy in the months ahead possibly with a bigger profit than they would have hoped for 6 months ago . gla.

3 years ago you would get 1% interest if you were lucky on any investments so if you can make 10% plus then you are quids in . I think 30p pre AIHL news from NICE is possible , then what will it do come next month when we hear the outcome especially if they give a date as to when they will actually sign it off??????

System . you have done the hard slog like a lot of us mate , now hopefully we will start to get the rewards you could well double your money come year end so alittle patience could well be rewarded , if we can hold our gains made this week then it will show a lot of positivity as traders will be looking to close their positions for the week . I still feel this has nt really started yet and i am surprised how high it has risen and i feel traders will look to load up nearer mid Feb and with only 3m ish shares bought we could well see a lot more bought over the next 3-4 weeks.

From what I can make out the fees for the De Novo route will be about 1 tenth of what was expected.

The final step is the De Novo request decision. Under MDUFA IV, the FDA's goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request. This is a copy and paste from the FDA site.

been doing a little bit of research into possible application .The FDA reccommend a pre market application when you have a unique product so as to determine what route to go down , De Novo or 510k following that you can then decide what route to go down and the De Novo route looks very possible . There is no time limit when to apply after this pre application so that is down to GDR to determine but the FDA try to work to 150 calendar days from request to completion , there are two criteria they like to see . 1 being medical results which we have as this test is currently under way and. 2 having IEC backup being Independant Ethics Committee which will be NICE . It is now down to the BOD when they apply to the FDA , which for me puts the company in a good position of control when best to apply . With NICE news due in February we are expecting the sp to be higher than it currently is so that could be a good time to look for a cash raise with less dilution AND THEN apply for De Novo , OR wait for NICE news and then apply to the FDA which should also increse the sp even more and then go for cash raise . But the BEST part for me is it gives the company a better understanding of possible sales and forward income so 5 months after FDA application if granted then sales could commence , with NICE conformation sales should start to pick up in the UK and Europe so therefore we may not need to raise 12 months burn costs of £5m but if we do look for a little less the higher the sp is the less dilution needed. In conclusion , FDA application in March then conformation in August with sales to follow couple of months after , NICE acceptance in May hopefully then sales to commence 3-4 months after so with a little bit of luck by q3 we could have somewhere near income month on month to start with to negate any cash burn . None of these dates are nailed on certainties but it just gives us a better understanding of what is possible and what is needed to increase the sp and reduce the amount of dilution so it gives all the long term holders the chance of not only getting their money back after these years but also some profit for the hard slog it has been .

Hi Ben , not heard too much, currently on TW site , they are getting rid of 2 assistant agents so no too big a cull over the region . I work for a contractor of about 150 ish chippies and only a few having a few days off here and there which is to be expected under normal circumstances here and there . As we know there just is nt enough trades about good or bad to meet the demand and until a proper training programme is set up nothing will change .
The oldies like you and me will be fine ,lol the younger ones who have not been through this type of event and used to chasing the money will suffer in the short term but i still expect it to turn around in a few months time when confidence starts to pick up . One BIG thing i have heard of is buy to rent by private equity companies and investors , it is big in the US and now coming over here and Europe, Barratts are doing a site in Bedford, 600 units 200 are H/A 200 private rental and 200 traditional sale so someone is going to be busy .

Morning Ben , not sure about TW but i heard Barratts have , they are now looking to focus on quality over quantity so expect trades to get picked to bits, rightly so as some work is shocking caused mainly by pushing by the companies . Pre Christmas the painters were given the weekend to get 4 houses completed for monday morning as the carpet fitters were booked , no wonder customers complain and then they blame the trades .

lioyd it is just a guesstimate hence the question marks , if there is a meeting next week then consultation next month then 5 or 6 weeks to sign it off , hopefully . With nice guidance in place then FDA De Novo is a lot more likely .

publication in April??????

Good luck with that Steve , not a chance of that happening .

avocet123 ,ita mostly due to market forces , there is a shortage of labour thus the demand is met by increasing prices. Over the last 25 plus years school leavers have been encouraged to go to university so the manual labour jobs such as construction has seen a trickle of apprentices compared to many years ago plus the builders have been reluctant to take on apprentices as as soon as they are qualified they will leave as direct employment is now a thing of the past so they see it as dead money . No matter what trade you pick even now they are a physically demanding job so working to 67 is out of the window , no sick pay , no pension , no job security so £50-60k seems a fair do . Take into account most trades will be on price work so if you dont put a shift in you dont earn the money.