Member Info for ButterMyCrumpets

FDA accepts data from trials outside the US for either 510(k) or De Novo routes.

GDR already have trials ongoing/completed for both products.

@EmeraldCarrots

That's exactly why CYP2C19 is going first, the fact that there are already approved tests means approval should be faster.

Target market for CYP2C19 is also much wider so better potential returns.

The Genedrive system will also be part of the approval, which means once they get round to FDA for MT-RNR1, the testing platform will already have approval, only the test itself will need review under De Novo. This will help speed up the process.

Funding right? They previously got it for free for the study, and now they need to fund it themselves.

I understand that the current published figures from GDR show that the trusts should see a net saving using this test Vs lifetime care of impacted children, but those hasn't been officially published by NICE as yet, right? They mentioned that it should save money but more evidence gathering was required. That should now be part of their full guidance expected in July 27.

Back to business, I've been thinking (yes it did hurt)....

If GDR have been paid through the Paloh funding for the study duration, for every trust that doesn't convert to BAU, surely we need to chalk that up at as a reduction in revenue right?

Not really sure what kind of reaction people are expecting from this?

Although the news is great, it doesn't bring any meaningful income in relation to cash burn. Hopefully the other trusts will convert into BAU as well, but for potential UK rollout we are waiting at least another 12 months before a decision, let alone starting the process.

Business aside, I'm stoked that families are starting to benefit from this test and children are being saved from potential lifelong hearing loss. It's changing lives already and I'm proud to be part of the journey however long it takes.

David got his seat at the table, great news!

And if there are delays/issues with FDA then that's time and money wasted as well as a potential redundancy.

Looks like a few pharmas are up recently? Panic buying because of hantavirus?

They need enough evidence generation for clinical & analytical validation for the submission. This process can regularly take 12-24 months. The timelines are probably based around this.

Nope, not expecting anything to be fair, would be interesting to see any numbers around the Scotland expansion though

Think the submit timeframes are within 3 months right?

So they have until Tuesday.

I can't see a buyout happening until this is derisked further.

The company may still need further funding in the future, as well as the extra cash required to complete a buyout.

Not happening anytime soon IMO from a consortium of private investors.

With breakthrough device designation, the timescales are typically accelerated, 3-4 months isn't optimistic

It's been nearly 2 weeks since they announced the proposed fund raise. Unless there is something imminent that may raise this further, GDR just need to get on with it.

Mr Nugent can't keep propping this up forever 🤣

We're just assuming the cash burn rate is the same here though.

Funds are being used for FDA, IP transfer & manufacturing scale up. This will all cost £££ so the runway will be less

85p-£1 is delusional IMO. We still have a rather large dilution to come, the hope is that we will be cash positive before the money runs out, therefore not needing any future funding from more dilutions.

I think 5-10p over the next 12-24 months is more realistic if things play out well.

All IMO of course!

Yep, never been so happy to see a fundraising RNS!

I'll be resisting any temptation to top up now and save it to actually fund the company directly.

No National Commissioning then for GDR's stroke test unless they can prove it's use in central labs (which they did say is possible).

POC testing will be on an ad-hoc basis on the needs on the local trust.

It's not great news IMO

Not sure why some people seem panicked over this loan agreement. Securing the loan against company assets is a common process with high value business loans.

If the assets are worth more than the loan amount, then any profits of sale of those seized assets must be returned to the borrower.

I see no ill intention here IMO, DN has more shares than the loan is worth at present, he would see overall losses if the company would to go into administration and forcing a sale to recover the loan.

Looks like it's only 5% right? £50k being applied to the 2nd trench, 1st being without charges or fees.