Member Info for ForFXSake

Maybe someday

Maybe someday

Hopeabound, the EMA ODD was passed but how exactly has that benefitted the shareholders or the company?

You would have thought, after telling us all how critical EMA ODD was for securing a partner, that they might have found one by now.

Instead, it seems all our eggs are now in the FDA basket which seems to have entered a never ending period of secondary review.

Jam?

The thing that is not similar between the EMA & FDA is the amount of time involved in dealing with the response.

The EMA didn't skip a beat in beingcable to address it. We didn't even know that a request for further information had been made until the 12th November RNS about the FDA query.

2 months delay so far.

Some people like to make excuses no matter what.

Is it ok to not like never finding out who the so-called partners are?

You say I shouldn't expend my energy 'whining' about continued failure to deliver yet NFX have wasted an inexplicable amount of time and energy on obtaining ODD which has so far delivered pretty much sweet FA.

Why don't you direct your energy efficiency advice towards them instead?

"No timetable" really?! just more excuses.

I'll bet we don't hear anything further now until they need more money again.

Same old BS.

Yes, just think, it's been 2 months responding to a simple request for further information when the whole ODD review is only supposed to take 3!

Where are the partners?

Well we do know they had received the request by the 12th November at the very latest. That's over 30 days ago! We also know that Dan Gooding implied it was a fairly straight forward repeat process of something they had already been required to do for the EMA:

"Dr Dan Gooding, Executive Director, Nuformix, said: 'We will respond to FDA using the data we already have on file, having previously had a similar query from the EMA. I remain confident the process will reach a successful conclusion and whilst we await the FDA's further response we continue to progress discussions with potential future licensing partners and will provide further updates in due course as appropriate'"

I woyud say that doesn't suggest any need for "widespread timelines" at all.

Lets not make excuses for continued delays which run down the limited capital this company has.

No.more excuses or BS.

Where are the partners?

"The extremely far-fetched, biased and bullish scenario would be where the FDA has responded and a partner is lined up but the partner has asked NFX to wait, until they can issue a joint RNS about a collaboration! But this is unlikely because insiders would have already driven the SP up."

Yes, extremely far fetched

My response wasn't actually a dig at you OSD.

I was just highlighting that it is pointless to expect anything in terms of info on tangible progress via an email request.

I suspect Soupdragon is correct in that they haven't even responded to the FDA yet.

They have their money from the fundraise so pressures off, back to the day job and park the hobby project until more money is needed. We will no doubt hear from them again when the money starts to run out.

Same old BS.

So sweet FA...as usual!

Where are the partners

"FX, hope you bought the dip"

I thought you wanted me to sell! 😂

I bought at the last raise and that will do until I see some further progress. Just happy that yesterdays blip appears to be just a tree shake.

I hope the company gets news before xmas

If it's a tree shake before good news or someone dumping before bad news, it points to news.

You might not have to wait too long to find out.

If the don't get FDA then they'll just have to forge a way forward on the back of the EMA ODD.

All we need is those reluctant partners

"those who don't believe will move on."

Or they are free to stay, ask questions about why nothing ever materialises and express opinions, if they want to.

I would have thought this year was ample enough time if they really wanted it for a partnership and had no more plans to fundraise.

No more excuses

This is the last update I saw from Nuformix, 12th November:

Dr Dan Gooding, Executive Director, Nuformix, said: "We will respond to FDA using the data we already have on file,"

It said they would respond, it wasn't confirmation that they had.

If the FDA do now have it then we should hear simething soon given how close to the deadline it was when they raised the request.

This is part of a response from Google to a quert about NXP002 FDA ODD Approval:

"FDA Orphan Drug Designation (ODD) Status:

Application Submitted: Nuformix applied for US ODD in August 2025.

Clarification Needed: In November 2025, the FDA asked for more information regarding the application, which Nuformix planned to provide.

Current Status: The designation is not yet granted; the FDA is reviewing the application after receiving Nuformix's response."

The current status is the interesting part. It states the FDA already have the response and are reviewing it.

Not sure how trustworthy this information is but (if true) it indicates that things are moving again.

Well somebody obviously wants everyone to think so judging the four 1 trades that appeared at the end.

You building your position again Chab? 😀