GreenRoc Accelerates their World Class Project to Production as Early as 2028. Watch the full video here.
Ok - but BOOM isn’t really expensive and isn’t in trouble , and I can’t see PI ‘s driving enough volume … however nothing would surprise me .. so best to be guarded - I think BOOM will make a statement , they have to really as it’s a formal press release and states they have informed the board
Allfair point ZAK ..Never trust anything .... but i'm not sure why you would wait all this time ot clear out a few percent.. Hes already lost alot BOOM and was forced into action as it all collapsed.. you may be right - time will tell.. but seems a bit expreme to offload his wifes shares
Hi All
I think you are barking up the wrong tree with the 510K/ Denovo debate .. I understand that Its all about evidence of efficacy and safety.. been though this before - From what I understand 510k Approach is because there is a baseline set by another application that can use the same/ modiified process for evidence validation .. De Novo is quite rare and a process where the former is not avaiable therefore the FDA need to agree a virgin evidence baseline to satisfy that this product does not put paitents at risk.. could argue that 510K is easier as you have a clear starting point one what needs to be produced..and possbly an easier access to medicare reembersement codes .. that said - This is a non invasive "no lose" test - it mitgates risk ... a bit like taking somes heart beat and blood pressure before sticking them on a operating table .. Im sure GDR will have built an eveidence file on the works done so far and that will inform the route - but the process is based on risk and efficacy and is dictated by the complexity of the case -either roure could be relatively quick or take years.. but it "should" be realtive simple as its a binary outcome without process intevention.. most companies are in the position of taking on FDA first.. but I think NICE route will mitgate the FDA evidence process massively
Agree .. looks complelling..
BAZ - I think we will get a resourse upgrade before Q2 myself - either way no rush , but looking at past compaines it normally flows through seperately in advance of the issued FS
I do also wonder if this Put option is part of a strtegic plan to get the 15% issue cleared and back in MAFL hands , but time will tell on that one - GLA
Agree -The last published NAV is quite out of date.. LS was valued at $1.6 million (I think) before we got the $2.5 million, so with this GS and other investment performance .. even if we valued LS at nothing NAV looks to be 26-28p share. Its nice and quiet, and the weeks are ticking by .. FS 8 -10 Weeks away and ASND's bullishly pushing on
All looking like the fruits of the hard work are starting to ripen .. Aonther point of note is that our stake in asendent is up over 50% and touching all time highs ... Roll on FS - Cheers
IMO - Nice approval is worth 10x that of FDA - NICE has power over purchasing- whereas in the US FDA is only a first hurdle - getting the medical insurance charge code after can take 2 years - not sure how it would work with something like this in the US - it’s not a cure /treatment or therapy but an “insurance” against claims .. as sick as that is .. preventing deafness in babies is not the top concern .. it’s all comes down to cost /benefit and in the US the cost benefit of something like this is huge .. but it’s a crazy land .. probably get the cochlear implant companies lobbying against the test !!!! And the lawyers make money from the litigation - but the underwriters of Medicare would have a very different view
It would make sense to partner / licence .. but only one step at a time .. I know this has had disappointments , but NICE are not AIM Rampers
And there recommendations are pretty clear -implement and evaluate
Watch there worse problems to have - if your product is wanted ..and makes money then there is always a way... partnerships , debt , equity - but that is not the concern should have now! the goal of all Medi tech is to get round the red tape and into use - I dont see why everyones so scared .. £24 million mkt cap .. Have you read the NICE recomendations ? Public consutation may ammend them slightly but this IS going into widespread NHS use IMO .. The rest is just time .. but there are companies much further away with a more complex patth , worth alot more than GDR
Also - If this is avaiable in the UK - How long before others realise that they are putting children at risk? likely to get sued for not offering a simple cheap £100 test - EU - US - ROTW , NICE will act as a evidence benhmark to support approvals , but the insurer and reputational risk that will drive the acclerated adoption
Hi All - UK will is the precursor for a much bigger outcome -with alot of demand .. FDA will fast track also .. its a diagnostic device.. not a drug .. 510K all the way ..risk based ... you think medical insurers wont wont this ??? great oppertunity .. uk may only bring in £6 million , but we are one country ..
In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage.
not huge volume - maybe someone adding - but agree we have see a pattern before an RNS ..its just not easy to buy in any numbers without moving the SP - Have a good weekend
Hi all
All the inofrmation of process, considerations for satakeholder and timelines are in the EVA NICE doumentation .. Saimple google will take you to the documetation .. there no need to specilate its all there
Quad - FYI the FS was due by Q1 -Its slipped to April in ASND's recent RNS- it contracually must be done Jume
MAFL has been leaky to news , but if the 15% was on the way and someone knew we'd be 100% up :)
Was expecting something on Goldens Gold financing and royalties but thats gone a bit quiet ..
news is never first thing so you never know!!
Morning - I think it may be sell the 5% - then legally fight for the other 15%.. looking good though , comfortable to sit back and wait Cheers
Thanks for the reply - agree - it’s not really possible to buy - I’m in the same boat - got cash to add , just waiting to see if an offer price comes in around 17p and will nibble as others get bored .. but it’s stood pretty firm over the last couple of months .. not exactly riveting but making good money never is
What’s your thoughts on the PEA v the infills we’ve had to date - I’ve tried to compare the two .. not easy task but in general all the drilling done exceeded the PEA and most metrics have improved.. PEA appears to have been constructed in a conservative manner
Yup :)