Member Info for bighammer

Heads or tails Guy, i am hoping it is the first one.

Roger , i am afraid to say i totally disagree as i feel we will get sales within the next couple of months , in saying that they are just my thoughts . I am not saying Budd is the best thing since sliced bread i just feel that AIHL is to good to fail .

MyIPA , cant find the link but it is on the FDA web site under De Novo , this is the route i am hoping for and that NICE accreditation eill aid that thus being cheaper and quicker . Hope that helps .

Crooty , my apologies predictive text.

Droopy, it depends which route we go down for application at FDA , the one which looks a possibility is in the tens of thousands rather than hundreds of thousands with 150 days notification .

Looks like we are all in very good company at least ,lol. Been there done that but managed to average down to 44p and i am more than willing to wait until £1 on some and will leave a % for takeover .

As we all know Starrs sometimes there is no rhyme or reason what the sp does , it is brave and honest of you to sell but i have been in too long to risk my investment for a couple of £k but without any news this may well drift to the low 20 s where we have seen the floor previously .

They also mentioned they were in talks with Greater Manchester regional trust so if they can work with regional trusts instead of individual trusts then all the better .We are in that wait and see stage again but at least this time we have an idea that we are going forwards instead of backwards.

Morning , your 15% sales prediction Starrs i feel is a little under what the bod are hoping for hence the reason going down the finance route they have . Of the £5m they could have had from a normal dilution they chose to go down the route they did with the option of the monthly draw down which says to me they either expect/hope for more money from some other source . We now have quite a few European distributors so we have no idea what will come from those but the company will have been in discussion about possible revenue , the real possitive/negative feedback for me will be either some sort of sales news OR taking up the drawdown option at the end of May as that will give us the poor sales expectation the company are getting as feedback , until then the sp could easily slide as we have witnessed many times , but get a few little sales from outside of the UK then who knows what will happen but the sentiment will definately be on our side and the market will also look at us differently i feel .

Starrs, was it GDR moved it to ETA or NICE .? I have a feeling it was NICE and if so it could be because they could see how good the potential is so wanted to get it to market so to speak as quickly as possible.

Roger , Riverfort are nowhere near as big as the pharmas out there and they will not let the products slip away that easily.

Lets hope other countries dont work under the same principal , i cant wait until we start getting sales from within Europe as there are many private health care bodies that will look to offer this test to their customers/ insurers.

Jackal, great explanation so the fact R have the warrant over 4 years makes me feel they have confidence in the company going forward and the excise at 44p to buy and only let on to the market at 15 percent implies they can't flood the market when they sell so as to distort the sp..
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Jaffy, get a bucket , hey presto back to 3.

A pre-submission (Pre-Sub) was filed with the FDA to agree the regulatory approval process of the Genedrive® MT-RNR1 ID Kit into the USA. The Pre-Sub process allows the Company an opportunity to clarify its testing and validation approach, confirm the appropriate regulatory application pathway, which are uncertain given that there is no directly comparable test in the market. The Company is in ongoing dialogue still with the FDA to ascertain the requirements, and consequently the funding estimate that would be required to conduct and manage the evidence generation and submission process.
I have read this a number of times and i cant see where it gives a timeframe that it is miles away from going for full application ?.

So this type of funding is taken out it seems a s a desperation type , last resort . Now if that is the case then god help us , another reason is for short term possibly in that you want some cash for a short term as you know or feel you will have income coming in in the coming few months or so , 1 is very risky long term , the other is low dilution for short term , I THINK so on the whole quite happy .

1DayRodney ,i am with you as i have not had any experience with this type , any sort of funding is going to have a detrimental effect so to speak on any share , the plus for me is we now have access to funds for the next 12 months to help with production of tests and machines for any sales we get and any application costs needed until we are in a position to be self funding . Sales will come from the UK but i see European sales as the big breakthrough for the company which for me is a question of when rather than if . We will never get told but it would be good to be a fly on the wall to hear the conversations if any they are having with our distributors outside of the UK.

We have just had a placing of 6.5m shares at over 15% ABOVE our closing price , what is so great about that lol. The finance report today was drafted before yesterday s news so they are right technically the company are still in discussion with the FDA regarding pre application . Now if a numpty like me who is completely useless with computers can find out what route we can go down regarding applications , what the requirements would be to help apply , how much they would cost and also the timescale for applications then anyone can , which is why NICE approval is so important and imo we will have an application in by the end of next month at the latest which would give us , fingers crossed approval by the end of September .

The Board is confident that the Company will see an acceleration of revenues through 2023 and going forwards. The NICE recommendation (if confirmed), given the health benefits and health economics, is also expected to facilitate the rollout of our AIHL product in both the UK and international markets (subject to relevant registration processes).
Check the brackets , this document was drawn up before NICE announcent yesterday. As for FDA application , with NICE accreditation this is a huge step to application and dont expect it to cost hundreds of thousands for the process.

Congratulations to all the long term holders that have been through the mire over the last few years , it just goes to show you that patience is a virtue , the share price is still going to get a little bumpy over the next months but only in a good way . Will we ever see the 20s again after next week ?, MOST DEFINATELY the only difference from today is that it will have a £1 in front of it . Have a great weekend all and just sit back and enjoy . PS thank you Mr Budd for looking after the shareholders , not many CEO s give a toss , you have just proven you do .