Member Info for bighammer

I hope we have had a chat with this guy, Rob Packard - Medical Device Academy. fot £20k he basically does your application to FDA for you.

The FDA offers various programs, including grants and funding opportunities through initiatives like the Small Business Innovation Research (SBIR) program, aimed at assisting small businesses with regulatory submission costs.

The FDA publishes an updated MDUFA fee annually. For the Fiscal Year 2025 (October 1, 2024, through September 30, 2025), the 510(k) submission fees are as follows:

· Standard 510(k) Fee: $24,335

· Small Business 510(k) Fee: $6,084

The FDA offers fee reductions for qualified small businesses. To qualify for the small business fee reduction, the following must be met:

The business must demonstrate that its gross receipts or sales (including those of any affiliates) are $100 million or less for the most recent tax year.

Companies must submit signed copies of the most recent federal income tax returns document for the business and any affiliates.

Manufacturers must create an account in the FDA User Fee System to receive an Organization ID number (Org ID), which is required for the application.

U.S.-based companies must complete Form FDA 3602, while foreign businesses should submit Form FDA 3602A. These forms are available for download on the FDA’s website.

There have been some optimistic posts over the last few days as to where the sp could be in the next month or so but10p-30p is fantasy land imo. even with FDA and NICE full approval will not see the top end unless there are some massive sales to go with it . With very good news and momentum could possibly see 5p which i feel the rapers are looking for getting in the current price but for the majority of lth s patience is still the key just set realistic targets.

It was said earlier that 90% of AIM companies fail and without CE FDA and NICE full approval and funding we will be one of those so with world market leading tests with the potential £200m per annum income what is needed to make sure we become one of the 10%. I think that within 2 years from now we will likely have all 3 which will see sales kick of as and when any come in so the question is how much will we need to raise to keep the lights on???? If you ignore the cash we have currently, we are at about £1m income per annum with all the bits and bobs we get and a cash burn of £6m a year so £10m . This should see us through to a place where we are self funding with all 3 approvals. I dont know if this is why they only went for £1m now with news later or because they could not raise any more. The markets are spooked as we have still not sold any significant amount of tests and machines but for me i would like the CEO and chairman to be in constant touch with NICE and the FDA to find out to the minutest detail as to what is required for approval and with this you have clear defined timescales to take to the market to raise funds baring in mind that this can be carried out at intervals . Yes it will mean more dilution possibly doubling the amount of shares we are currently at but that would be far out weighed with the increase in the sp imo ..any thoughts ???????.

Going on timelines we should have FDA approval before NICE then ?????

Dont tell Rachel she owes us money she will want the £500k back

Stocksaint, according to their application proccess they will also look at data collated from other respected bodies of which NICE fall into so with the trials going on in the US and with what has been gathered then surely we should be ready, now we are going down the 510k route and not De Novo which takes longer and more expensive????? just more questions than answers, one thing i am confident of is the tests will succeed if they can keep raising the capitol.

What i cant fathom is we first approached them 18 months ago , about 12 months since the US partnership was set up and loads of data from functioning hospitals , what else or how much before they actually apply, this is a test not a drug and as stated a low risk one at that so what is the delay with the aplication?.

Gloria, at present you are correct but a n ideal time to average down at these prices , now in single figures. If we can get 12 months running costs later this year where do you think we could be in 12-18 months time?? possibly beak even .

Any of those will just add more solid building blocks for the foundation of the company to progress. I think we may get 3-4 of those but until we start to get solid contracts and sales nothing will happen to the sp. None of this will impress the markets imo no matter what we all think in the short term vut i am very excited on where the company is headed over the next 12-18 months and beyond.

It is becoming quite clear that the markets wont react until we have sustainable contracts worth a few £m . Now that is going to take time but with the latest uptake the medical profession have confidence in the tests so it looks a lot more like when and not if . Also take into account the shareholders are also becoming a lot more savvy and cautious, for eg the latest news HE1 have had would have resulted in at least a150% rise a few years ago, now they want to see flow rates logging details etc , but what this does is when the rise does come it should results in steady sustained rises instead of peaks and troughs .

So based on that statement who would nt want to reduce 17 days down to 60mins??. If the stroke and hearing tests were taken from labs then that would free them up for other tests and get them down to 16 days.

as regards FDA and NICE approval, there is one massive factor between the 2, NICE not only have to prove the tests work which is now beyond question, but also financially viable which is why they currently prefer lab tests wheras the FDA only want to know if it works, the funding part is left to the hospitals and insurance companys and as far as i know as this is not a drug then the FDA will accept all data and evidence form other renowned and respected authorities.

We know the FDA and NICE work hand in hand at times especially on non drug approvals for eg, last year the FDAapproved the air pod pro as a hearing aid and test with the app and this is due to be given the green light here based on FDA data. Now we all know this will not be the case all the time which is why ithink the partner in the US was taken on to assist with the aplication and data and going down the De Novo route gives us a timescale of how long it will take as they set out 150 days for a yes or no . The big question is when will they feel confident enough they have the data to apply???.

Docket Number:

FDA-2013-N-0080

Issued by:

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

On February 21, 2018, FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. Under the new rule, FDA is requiring that data submitted from clinical investigations conducted outside of the United States (OUS) intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a humanitarian device exemption (HDE) application, or a product development protocol (PDP) application, be from investigations conducted in accordance with good clinical practice (GCP), which includes review and approval by an independent ethics committee (IEC) and informed consent from subjects. The GCP requirements in the final rule encompass both data quality and integrity and ethical standards for device clinical investigations.

Pure guess work on my part but i think the BOD are hoping with news due they can get a steady flow of income even if its only £500k to start with and the sp re rates so as and when they decide to get more funding then any sort of discount will be lower than previous raises. But as you say the markets are not great so income streams are a must .

I dont think they need to as the current machine already works for the tests more like they can improve the machines to make the tests more accurate and faster, possibly. If it aint broke why fix it unless its to make it better.

Some are in for the long haul due to their average and some as they hope it will pay the bigger rewards, lets say in 2 years time we could have FDA approval along with NHS rollout and hopefully sales elsewhere, taking into account likely fundraises where would the sp sitting????.

I think commercial traction will be needed for offers which may not happen until US approval and sales which could be 2 years or so, but i feel it may well be worth the wait which is why i am working at getting my average lower , (35p -11p so far)but we can only guess what will happen . All the news we are getting is positive but sales are what is going to drive the sp and so far they are a bit thin on the ground.

If somebody could assure you with some certainty that in 2-3 years time that the sp qould be 20p plus then would you hold for gold and even buy more , or sell up as soon as you were at money back stage . Now we all know that nobody can state this with any degree of accuracy but with what news we can hope to get i feel it is POSSIBLE , hence my position but it would be interesting to hear others views.