Member Info for stocksaint

EM, NICE decision making covers England and Wales. Yes, Scotland is separate for this (not covered by NICE)

Or even 7 years ago...they started trialling the MT-RNR1 test in 2018!

Suspect the outcome might have been different in terms of where they are now commercially, if they'd of used some market access/regulatory consultants about 5 years ago. I think the advice would have been to go for FDA on the babies product much, much earlier. If they'd of done that they might even of had decent sales in the USA by now.

This is basically why FDA approval would guarantee SOME significant sales. The USA has different payers, and there's quite a lot of flexibility. But EU is another matter: for signficant sales you need separate national payer approvals in each country.

Much rests on the NICE decision. A positive outcome, then they would be able to raise money at a higher level anyway. (still also FDA decision to come, that should also help, but timing seems uncertain).

Wes Streeting doesn't decide EM. It's a NICE committee of health professionals that makes the decision.

It's saying if they get the NICE greenlight, first orders under national rollout should be in the middle of next year.

Executioner,

GDR has always been like this. No change really.

No point having more sales people if national payer approval doesn't exist.

If they'd of submitted an application to gain market access approval in any other country in Europe we would of seen it in an RNS. My guess is for Europe they hoping to get NICE approval first and then use that as a basis to gain accelerated approvals throughout Europe. (obviously I not talking about clinical approval, its about European national payer approvals)

Hoping for

In my view, Prof., certain shareholders were very committed because one they were heavily underwater previously and decided to average up, and two because they hoping from approvals from NICE and FDA to come.

EM, Other European countries have their own version of NICE as well. You could ask GDR if they are currently trying to progress any market access approvals in European countries (apart from UK) and how far they've progressed with that and when approvals are expected. There was only a vague mention of this side of things (EU approvals needed) a few years ago by Mr Budd but I've never heard anything else from them. They've had distributors before in the UK (and that was when they had no approval at all to actually sell the product!)

Lol Emerald, I think folks trying to explain to you that GDR needs full NICE approval and/or FDA greenlight to get on path to signficiantly higher sales. You just aren't going see much change in half year report. I guess will be published this week.

It probably makes investing in emerging markets stocks an irrational thing to do - or something that means you require a much higher risk premium. If a government can just seize your investment at any moment with no consequences, then this changes the whole game, surely. (luckily I wasn't still invested in Burford, but I could easily have been.)

I not been in this for a while, but really can't understand how Argentina could have won this appeal???

Not yet. Biding my time at the moment, with all this madness going on.

Full NICE approval would be absolutely massive for GDR as that's an actual major "payer" decision.

The cost of fascism is very high.

Paddy, Personally think GDR's big mistake was not going after the USA much, much sooner for babies' product. (obviously not guaranteed that it will take off their commercially but still very good chance in my view. Crucial will be getting insurers approvals in USA post FDA to generate signifant sales there). They still may eventually get the NICE approval they need for England and Wales as well...but probably sometime after FDA approval lands in my view.