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BItcoin chart looking extremely bearish today

Slacker,

They would definitely get SOME sales in the USA within a fairly short time scale of FDA approval. However, what's not clear at all is how much sales they would achieve. That remains to be seen. If they got funding approval from insurers in the USA within a couple of years though that would also help sales there.

"why aren't we recommending it?"

NICE (England and Wales) said it wanted this done by lab testing, so that gets the central funding. NHS trusts can use GDR's stroke drug marker test, but they need to fund it themselves.

Yes, going for FDA first makes more sense. It's easier to get positive decision than NICE (and quicker).

It's not strange at all. Perfectly understandable. They are still waiting for NICE to make a decision on NHS funding approval for the babies antibiotic hearing test (covering England and Wales). For the other one, NICE ruled that it wanted lab testing as the primary method.

It would probably take GDR about 8 months just to design a Hantavirus test for the POC, lol

NICE - no chance whatsoever it will come sooner than GDR have indicated (they always give the most optimistic scenario)

FDA - no one knows for sure when, but something for the hearing babies test was meant to happen this year.

Raffs, The NICE decision is over a year away, according to GDR. What money will they have left by then? Or what will the next raise be at?

FDA could come sooner, but would still take some time to generate meaningful sales in USA post positive FDA decision. So even if both decisions are eventually positive, to me there's bound to be at least one more raise before they breakeven.

"I just wish the market would acknowledge the improved position GDR is now in.,

I think it's in an improved position in terms of USA because approval for the hearing babies gene test should now be quite near. And you're pretty much guaranteeed SOME sales if you get FDA.

In terms of NICE, I wouldn't say it's position has improved - we won't know that until July next year!

"The PALOH-UK programme is scheduled to complete by July 2026, with subsequent NICE review and issuance of final guidance communicated to be approximately July 2027."

There's hope they might get positive FDA news this year, and hope of positive NICE news next year. That's it.

The problem for GDR is just that NICE hasn't made the babies ' test official guidance yet. (In the case of the other test, NICE didn't make if the official default solution, and instead recommended a lab test as the default option). Loads of companies don't get their way with NICE, sometimes even big pharma.

This isn't true. There is a pathway. A NICE committee just needs to make it official guidance so then it would get central NHS funding.

Redmile are lending more money. But value of new loan is not disclosed so far: see registration of charge doc,at top of this page:

https://find-and-update.company-information.service.gov.uk/company/07368089/filing-history

I think most NICE decisions are 50/50. They consider a lot of factors. Social, economics, medical etc....in the decision of one of the biggest single health care payers in the world, the NHS in England and Wales.

FDA decision is different because it's not a payer decision. The USA payer part of it is done separately later on, by different entities, and also individuals.

I beleive it could go either way Mum, in terms of NICE approval. I think 50/50. If they get that it will be big rise. But if not it will drop hard. On the other hand, I believe FDA approval is much more certain, extremely likely. Unlike NICE though, the timeilne for FDA decision is more uncertain.

If they get NICE approval, I reckon share price would go to at least 4p because it currrently far from certain that it will happen,and also if granted it would make other payer approvals across Europe and the world more likely IMHO.

It's just that market access isn't really easy in most countries EM. USA is about the easiest because FDA isn't making a payer decision. NICE for example is completely different - a much tougher nut to crack. If you ask me chances of full NICE approval are 50/50. Chances of FDA approval are over 90% (but the timeline of the latter is uncertain). GDR should of gone for FDA far sooner in my view!

You might never hear anything else about it. Even if they trial it in one Saudi hospital for a couple of years, they still might not even decide to take it any further. And Saudi Arabia also have their own version of NICE as well.

It not quite like the USA. NHS tells people to suck it up - it all about national decision making for the "greater good". (perhaps in some cases people can sue NHS here, but I think very difficult for most people). I'm not a lawyer though.