Member Info for GIVMESUNSHINE

Morning re DHT

My thoughts - I’d you check clinical trail one the primary end point is the measurement of Cellular immune response.
https://clinicaltrials.gov/ct2/show/NCT05329532

There are four types of hypersensitivity

four types of hypersensitivity are:
Type I: reaction mediated by IgE antibodies.
Type II: cytotoxic reaction mediated by IgG or IgM antibodies.
Type III: reaction mediated by immune complexes.
Type IV: delayed reaction mediated by cellular response.

So FWIW from my layman view - DHT is a very good sign that at least one of the primary end points is being met ..Cheers

ading the RNS again it would seem that the results that we were presented were from the dose finding Arm and not the expansion phase started at the end of October? reading the text below the reluts are ver early.

As no dose limiting toxicities were observed in the monotherapy dose escalation cohorts, patients continue to be enrolled into both the ongoing monotherapy expansion cohorts and the CPI combination dose escalation cohorts during H1 2023.

Thanks all

Ive been trying to get my head round it …I didnt know about the first being 3 patients – Expanded end of October -Assume this would be both C1 and C2 in the expansion phase? or C2 only - Then in Jan 14 prople dosed in expansion.. and then at last update Feb – 23 given (in total) … but I whats not clear is how often the dosing is repeated and where the checkpoints are 8 12 etc .. I cut n paste the below into word to work it out .. anyone aware of any other documnetation .. I have read the AGM .. But doesnt go to a lower level

13th June
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces the enrolment and treatment of the first patient in its multicentre Modi-1 clinical trial (ModiFY) at Imperial College London, Hammersmith Hospital.
16th Aug
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces that the first patient in Cohort 2 of the multicentre Phase 1 Modi-1 clinical trial (ModiFY) has been enroled and dosed. The dosing follows approval of the dose escalation by the Safety Review Board.
31st October
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces that the first patient in the expansion phase of the monotherapy arms in the multicentre Phase 1 Modi-1 clinical trial (ModiFY) has been enrolled and dosed. In addition, Cohort 3 of ModiFY is now open for recruitment in combination with a checkpoint inhibitor (CPI). Expansion into the monotherapy arms and the start of combination dosing follows review of the safety data from the Cohort 2 patients by the Safety Review Board
27th Jan
Fourteen patients enrolled and dosed in the expansion phase of the monotherapy arms in the multicentre Phase 1/2 Modi-1 clinical trial (ModiFY). First patient dosed in Cohort 3 of ModiFY in combination with a checkpoint inhibitor (CPI). There have been no safety issues to date.
Feb
To date, 23 patients have been vaccinated with Modi-1 and all have had skin reactions at the injection sites consistent with a delayed-type hypersensitivity (DTH) reaction indicative of a T cell response. So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8

Morning
I have been lurking here for a while, some useful posts on here - After following for a while bought in day after RNS..
Silly question - of the 14 paitents tested -How many were Corhort 1 / Cohort 2 ? I've looked through the RNS's and find them a bit confusing as first paitents were given the vaxine some time ago .. TIA Cheers

This has to be RNS'd either way

On 15 February 2023, Eliot & Luther (“E&L”) informed the Audioboom Board and its financial
advisors that it has entered into an initial Consortium Agreement in respect of ordinary
Audioboom shares representing more than 10% of the current outstanding shares

I think around thia level there is no real benefit in Xak theory - However something is definately up .. either an scheme to decieve..or the first steps in aquiring BOOM on the cheap .. wouldnt be suprised if the future members of the consetuim aleary have thier 29.9 percent

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