Member Info for Soupdragon78

I don’t… but the fact that the company hasn’t even mentioned orphan status in any of the rns’ or even Dans interview, in the four months since the telegram post does make you question it.

How do you know it was Dan on telegram?

Has it actually become the ‘holy grail’? I only see people here talking about it.

I’ve yet to see the company say they are applying for it, hence I don’t think they’ve applied for it.

Fairly generic overview article from Trinity College Dublin, in which the conclusion is that inhaled therapy for ILDs is attractive to pharma companies.

See table 2 where Nuformix are referenced.

"Finally, working in the rare disease space, with the associated reimbursement potential, makes developing aerosol therapies attractive for pharmaceutical companies. It is the author’s opinion that inhaled therapies for ILDs hold a lot of potential and are definitely not a lost cause."

https://www.tandfonline.com/doi/full/10.1080/17425247.2024.2348659

The timing of orphan designation application is related to the amount and quality of data that a company has available to submit.

The below sets out what is required for submitting, which is quite extensive.

It’s likely that nfx has only recently got sufficient data to be able to make an application for Orphan status.

https://www.scendea.com/orphan-drug-designation-in-the-us-eu-gb#

‘If we go for European orphan designation…’

If…

So it’s clear that at the time it was said, they still had t decided whether firstly to go for orphan designation, and secondly whether to go for EU or US.

Then there is the fact they didn’t cover it at all in the interims.

Remember, a company doesn’t have to announce that they haven’t done something that they haven’t announcement they might or might not do.

In terms of ‘blame other posters’, you were the one who said the 90 day period was up without even making the tiniest effort to research when the actual process started.

So who else is to blame for your own factually incorrect post?

Has it ever occurred to you that they haven’t submitted?

Does a company have to announce when they’ve not done something that they haven’t announced they would do?

Hi FX, I’m struggling to find your info on the procedure starting on 27 March.

I can only find the EU orphan designation website that tells me that applications submitted by 27 March start their procedure process on 22 April.

But hey that’s only public knowledge and a 1 minute search on Google so I guess it’s probably not as correct as your bias opinion.

Oh ok fx, so how did you get to your conclusion?

Thanks FX have you got a link to confirm that the review starts on the 27 March.

Fx, does the 90 day assessment procedure start on the submission deadline day? Or at a different point after?

If anything from the transcript it seems very much a case of go away and come back when you have got orphan status.

Robbo, I personally see it as being September sometime.

I don't think they will have submitted in March, given what I saw in olderbutwisers transcript of Dan's telegram conversation, they hadn't decided whether to go for EU or US orphan status. Then they would have to compile all of the data into the right format to enable the committee to review.

Dan said they 'wanted to start the process immediately' which to me means getting things ready to submit and I think that will have been after the March deadline.

Yeah, nfx reversed into Leverett.

No surprises our kangaroo friend didn't last long.

Feels more like 1917 goup!

Easy bet that kangaroo won't be here by the end of the day let alone tomorrow.

Thats impressive Goup, especially considering NFX listed in 2017

Classic case of a trader jumping in here not realising the spread, then panicking and desperately posting trying to get the sell price above their entry.

Good to see recognition of the patents we know were signed off.

Still no word on whether they’ve submitted for Orphan designation yet.