Member Info for Transhaven

Tonto please do not talk as if you were talking from a position knowledge. You have zero knowledge of the FDA or what the turn around times are and you post out stupid nonsense like 86% of FDA staff were employed were retained - I mean what utter trash - how would you know? AI? What source is the AI looking at? Internal HR data of a US government organisation? Bah! Nonsense that data is highly classified and there is zero way anyone on here would ever know.

Stop being a prat and admit that like EVERYONE else on this board you know zilch. Zero.

86% my ass!

Oh dear Hopeaboud - a bit defensive on your investment to the detriment of clear unbiased thinking!

We do not know the detail so everything we write here is unproven speculation - so stop being a rude little turd Hopeabound and start to have a more balanced view on what is going on. Dan and team have messed up lots of time in plain sight of everyone so there is form, hence my comment. The majority of LHTs will be of the same attitude as myself on this. We are still hopeful but our eyes are wide open.

GROC - about to be banned by UK.gov!!!!

Knowing how government departments work then actually all the effort will be on the KPI which is the initial response. There is no KPI on the post response review so..... this could go on for a very long time. Hence it being vital we got it right on the initial application and it is doubly annoying seeing as the EU version also requested the additional information. However we do not know the ins and outs but I am pretty sure this is a Dan mess up again.

Those invested are unfortunately powerless to effect any change or gain any clarity. We can make noises about withdrawing our chump change investment and run the risk of missing the boat but that is about it.

Join the waiting game or leave.

There are no partners because we have no approvals as yet. It is just PI rumour that says we have partners signed up just waiting on FDA approval - no evidence.

It is very frustrating that Dan submitted an approval to the FDA that was insufficient to pass - even after he/they had years to get the approval application right. However we do not know the detail and it could be the FDA being difficult.... who knows.

What we do know is that things are out of NFX's hands now and we just have to wait on an American governmental body making a decision. Could be days away could be months, who knows.

Us LTHs can wait a few months! It has been nearly 10 years for some of us.

Good luck all.

Welcome back to posting Goup.

I think I originally invested in NFX in 2018, it was in the days of Sailorboy who used to be called Aim4Utopia who was our most prolifically nasty poster I think! Then there was Amberdeenman that brought a lot of PIs into this and COPL a Canadian dodgy as hell oil "producer". FFX seems to be more positive of late which is a nice turn.

I see lots of rampy barrow boys trying to push the sentiment up which is hilariously transparent but hey ho why not (RIP Jay).

It would be great to finally make some money out of NFX with all the nonsense we have put up with over the last 7-8 years.

Out of interest when did you originally invest Soup?

OK see you all in January then hopefully with good news from FDA and then the next stage is a partner. I do not recommend Bumble.

Happy Christmas all LTHs and Dan and team.

Looks like no eggs in the basket in 2025!

Lets hope for lots of eggs in 2026!!!

But Soup he wants to believe and if that is good enough for Fox Mulder then it should be good enough for us.

😁🤣

Awesome! lets speculate away. I speculate that it will take some time to find a partner after approval.

No one posting on here will have any clue about any potential partner but I am sure people will speculate.

I thought that we knew that already - NFX responded we are waiting on the FDA now.

Git some more Chab! 😁

For balance: a 5 million sell = £12.38k

So not really indicative of anything other than itchy feet. However the silence is deafening

If it had then we would know as someone would have bought a pile!

I also predict the PnD crew arrive back again soon.

"Does anyone here use iWeb and still not received share allocation yet or money back?"

@smiler I use iWeb and can see the %allocation but no value, it should show you the amount though. Double check as mine are definitely there although no values.

Also iWeb are actually really good on the phone, the guy was awesome - I would just call then to double check everything.

Oh and sorry for mentioning your name as a PnD merchant if you are a genuine holder, you started writing at the same time we had a PnD crew on that was all.

??!!

I don't think we want that kind of weird talk on here mate - stick to the stock.

A quick look at the RNS gives the clarity:

So the FDA are the ones approving Orphan drug status (hence the confusion). So what Big_kahuna is spot on:

"Nuformix isn’t close to FDA approval yet. Their lead asset is a reformulation of an already-approved drug, which helps on safety, but the FDA still needs clinical evidence for the new form. That means:

1. PK/Bioavailability trial – to prove the new formulation behaves the same (or better) in the body.

2. Phase 2 efficacy data – to show it actually works for the intended indication.

3. Potential Phase 2/3 or Phase 3 – depending on results and FDA feedback.

4. NDA submission + review – fastest route is the 505(b)(2) pathway with a 6-month priority review.

So the process is faster than developing a brand-new drug, but still requires proper clinical trials before any chance of approval. The company’s next major inflection point is securing a partner to fund those trials and move the asset into the clinic."

Yeah I am much less excited now! Still worth keeping your money in and forgetting for a year or so, I originally investing in 2018! If this was Dan's main focus then the man would be a good candidate for ADHD or just lack of attention syndrome.

Could a knowledgable LTH please comment on the recent posts made by LTBeliever and Big_kahuna.

I thought that we have orphan drug status and were now going for FDA approval and the FDA wanted evidence of one more thing before they approve.

Once we have FDA approval we can get a partner.

Now Big_kahuna is saying we do not even have orphan status which were going for at least 2 years ago when I last looked into NFX then pulled out in horror at what a shambles it all was with fakers in the telegram group.

So what is it? Orphan drug status does not justfy the insane SP increases over the last month, yes we had a full on PnD crew on this (Smiler, apps, etc) but I thought it was FDA approval we were about to get, then talks of a partner.

If is it is just orphan they I am taking my money out (hit break even at 0.2) as this will only go on for many, many, many more years. It is clear to me that Dan and others in NFX are clearly employed elsewhere and NFX is just a little side gig that either happens or does not, it does not matter to them much.

Well I am a believer !!!!

lets get that 0.3 breached 😊