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I was just having a lazy, rainy Sunday afternoon so I watch the last investor meet presentation again and had exactly the same thought. Also German revenues should start to appear and it would be great for further NHS regions to take on Lipidin Code as I think that the North East trust alone can bring in £40,000 / Month which is £480,000 / year. News will appear soon we hope!
ROCA news might come in march if we are lucky .
NO EMAIL reply and wont waste time again if they have no interest in replying. . MY next buys will be in april as nearer fda decision .NOT buying now only to see it drift on no news . Pain full lesson here learned. Wont happen again
FDA Review and Decision for De Novo Application Approval
The FDA reviews the De Novo submission application for completeness and accepts (or rejects) it for substantive review within 15 calendar days. For substantive review, the FDA ultimately evaluates whether the device’s safety and effectiveness “can be assured through the application of general controls or general and special controls” and grants De Novo classification, creating a new device category. This classification creates a new regulatory pathway for other manufacturers to follow, as they can use the 510(k) process to demonstrate substantial equivalence to your device and share its product code.
While the FDA targets 150 calendar days to turnaround a De Novo decision, De Novo reviews can take longer than a 510(k) review as they are considering your submission with no precedent for its safety and effectiveness. If you receive an Additional Information (AI) request from FDA about your De Novo submission, the FDA will pause the clock on your submission’s review time. You must respond to the AI request within 180 calendar days or your submission may be deleted.
I don't suppose that the BOD are required to notify us of any requested (AI) during the process but it could make the process a little longer than the 150 days. It would appear that CIC score kit is effectively in the low to moderate risk category as far as the application is concerned so let's hope the company sail through it without delay and we can see some upward sp price action within the next 6-8 weeks. A successful De Novo application would set a new clear application pathway for our other products using polygenic screening to following in the future so it could be a good positive going forward for GENICODE DYOR and GLA Swissy.
No reply AND JUDGEING BY WHAT PEOPLE SAY HERE DONT EXPECT ONE . IT is what it is as long as they get fda im fine with how they are
Makes sense, thanks for the info!
I did send an email 2 weeks ago to ask for the company name that the application was made under as I was informed from another BB that it is not always the obvious company name as some use agencies to assist in the application. I then went onto the FDA De Novo application site and it appeared that tracking that form of application was only accessible to the company direct as log ins etc were required. I have not had a reply to my email but it appears that De Novo takes approx 150 days without and further product evidence requested so from the RNS that looks like aprox 27th April which would tie in with the Late Q1 early Q2 suggested in the De Novo RNS, so I'm no clearer than that.
I’ve sent a few plus contact MW through LinkedIn but no response.
Need to know if the fda application is for class1 or 2.
When exactly was the de novo application submitted.
Have they been given a response date by fda or is it just an assumption. De novo process takes much longer than fda clearance.
What is the application number, we should be able to track it on the fda site, from what I have seen.
Awaiting reply
IMO, they will have to raise but it will be far easier if they have FDA approval. They will need revenues of ~8m to breakeven.
Anyone know what’s the 510(k) submission number? I was trying to find Cardio Incode on the FDA site but no luck.
Has anyone managed to communicate with the company ?
Hi @tghussain at the last investor meet presentation it was suggested they would be looking to raise circa £8m so do you think they would be looking for a top up raise after FDA approvals or do you feel as I hope that revenues are strong enough to support company activities in the medium term. Cheers Swissy
By my maths, we have enough cash until sept/oct.
We can’t afford any hiccups with the fda/de novo approval. If we can get the approval in the next few week then I can see this self sustaining business very quickly.
If your purchases started at 7p and you have averaged down then you should be in a very strong position going forward Scoredagainsteps as I had a small purchase at IPO that I left unattended 40p. I Have averaged down since but this share has gone down on extremely low volumes and so should shoot back up again when volumes increase IMO. I have found on AIM it is extremely difficult without news to predict a bottom but we have revenues starting to be generated a recent raise in the bank and as close to FDA news as we have ever been so sit tight and we shall see. GLA Swissy.
I HAVE great faith im a seasoned investor and should have realised times are different to before when fda was coming up . PEOPLE wait to last minute now to buy . ITS MY MISTAKE i bought from 7 p to 3,87 approx . Im fully loaded however i will need to buy a lot more in the low 3/s to get average down . Thats not a problem however i been reckless diving in to soon . lesson learned .Good luck all may we get what we want and it helps people out
I have faith it will come good too but MW has to provide more frequent updates or at least do more PR.
This is a revenue generating business with an increasing work force so I expect more news on deals/collaboration/expansion.
Yes I totally agree donmac101 but personally although frustrating it doesn't concern me that much being a LTH. As I said before we have a relatively small team and M. Walls always stated that performance will speak for itself. The directors are heavily invested here and work load right up to any FDA announcement will be tough for the team. I feel positive that when sales figures come in that they will be on track due to the conversion rates by the experienced sales team they employed from EVERSANA I think!
I'm going to go back and have a look at my notes I have kept since IPO as I find it helps to remind myself why I am invested here and a believer in its future success. I will post some here for others when I have time and would welcome any other views and expressions so that we can form own PR!
Here is hoping for a lift out of the blue, GLA and DYOR Swissy.
As i have repeatedly expressed in previous posts this company is not interested in PR
Results due June.
Next news is FDA .Iam srill a buyer but they need to realize we are not mushrooms.
Must*
There much be updates for Lipid incode. De novo approval is for cardio incode
Pretty poor PR and zero response from the company to my emails/messages. Feels like the MC is tracking the daily decrease in cash position lol.
The company is dead silent, which is not instilling any confidence after the unfortunate raise. I whish they would announce some preliminary H2 numbers, but I dont think this is in their playbook. So just waiting for the FDA now, not much else to do ...
JUST TICKED DOWN AGAIN im in but wished i waited as i hold a lot so every tick down hurts .
We see
Nice one GoldBlend I can't knock you for that and it does seem like an opportune buy in price at the moment. Cheers Swssy.
Yeah,they've re stocked....but where they getting um from?
gotta be a back ground order,being filled,surely?