Member Info for Soupdragon78

The supposed email was made up by the poster, it contained discrepancies that even Tim wouldn't make.

He had responded to another question the day before, this was used then to fake the FDA comment.

You're not Shirley Valentine are you?

Dansey, the United Therapeutics link is very pertinent today as their stock has just fallen 14% today due to competitor success with the same treprostinil.

Also worth noting that United Therapeutics have been fighting a legal battle over a number of years against Liquidia over their inhaled formulation of treprostinil, with the Supreme Court rejecting Uniteds claims of patent infringement and saying that its 'unpatentable' due to prior art.

Littlened, if you're campaigning to change the global pharma clinical trials system and its methodology, I'd guess that an anonymous forum for a tiny pre-clinical company might not get you very far.

Littlened. Nobody is here for the patients.

Littlened, thats why pharma is high risk investment.

Very expensive with a high risk of failure.

In a very basic sense for NFX, they work with a spin off from Newcastle University called Fibrofind.

Fibrofind take lungs from IPF patients who have either just had a lung transplant or have just passed away. They then have a technique of slicing them (PCLS - precision cut lung slices) very thin, they can then test drug substances, in this case NXP002, and measure material change, absorption etc and compare to known responses.

All a lot more complex than this but thats the basic approach.

No, preclinical determines whether you think that something might be worth following up.

Clinical tests are very expensive and nearly 90% of drugs don't get to the end of them, so you need to have a good way of deciding whether its worth pursuing in the first place.

Littlened, NFX haven't carried out any trials at all with NXP002, only preclinical testing.

Clinical trials are not just a safety test but also efficacy, drug companies never really know how effective they will be until they test them. You aren't going to do this whilst in the market as you'd have law suits coming out of your ears!

For NFX, there may be opportunities to go straight to phase 2 depending on background information on Tranilast as its been in use in Japan for a number of decades. This would knock a year or so off.

Also I'll draw you're attention to table 2 and the report attached to the below.

"In conclusion, the technology to reach the fibrotic regions of the lungs by aerosol delivery is available and a number of already (orally) approved drugs as well as new modalities are currently in pre-clinical and clinical trials to the inhalation treatment of ILDs. Delivering to the site of intended drug action reduces the systemic burden and hence increases the safety profile of the medicine. 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#d1e183

Hi Dansey,

Just to help you out, here's a list of all the current IPF clinicals. 33 ongoing.

You can then filter it to inhaled and there are 3.

voila!

https://www.pulmonaryfibrosis.org/patients-caregivers/medical-and-support-resources/clinical-trials-education-center/pipeline?&conditions=3d449494-428f-46bd-8fd2-80826ed64efe

Not going to happen, wouldn’t waste your energy thinking about it.

Dansey,

The company has always stated they are not taking this to market, plus there is more than one way to skin the cat (i.e you might not need to do all of the clinical trial phases)

There's not actualy that many clinical trials ongoing at the moment for IPF (and only a small handful looking at inhaled treatment) and its a much sought after sector given there are only two drugs that have ever been approved. Plus most trials keep failing.

The major benefit of an inhaled therapy is that it directly targets the lungs, as opposed to oral therapy where you swallow a pill or liquid and your body has to managed its effect across multiple organs.

So a patient could be using one medication for an underlying issue and then use NXP002 as an inhaled therapy as well because it would not interfere with the base treatment.

Look at the recent RNS's, they tell you where the value is being seen. The 9th of April was very significant imho.

Well I guess that means I must be.

Anyway, happy with the progress made here over the past couple of months. See you all in a couple more.

OSD, as you'll be aware from your research, NFX have no staff and Dan as Exec Director is part time and not drawing a salary.

Work is done through external consultants.

Hi Mars, whilst they have the data, the FDA submission is based on a different set of submittal forms and requirements.

Also for FDA ODD, it needs to be submitted by a native US based consultant, so NFX will have needed to appoint someone over there to do the submission for them, just as they used Boyd Consulting of Dublin for the EU ODD submission.

The consultant will feed ensure that everything is as it should be before submitting so as not to waste any opportunity.

All is on track.

Ok fine, you’re right as always. No need for me to post here anymore.

I guess you can’t evidence your point then

Ok show me where it’s happened before

FX, so you are saying that a company who is involved in insider discussions with NFX should actively buy shares and tell everyone that they are doing so?

You really don't get it do you?