@JeremyFalmouth@Anthony_TayIor I understand it's a superiority study, what puzzles me is the exact success criteria. I mean primary endpoint is <15 letters at 36w, but nothing is said about rescuing. Is it number of patients who needed "rescuing" in AX arm vs afli and what's the "required" proportion then?
@Anthony_TayIor Can anyone help me understand what was the point of designing such study, where you don't even understand what are rescue criteria and what is a satisfactory end result?
If Trump wants the US to pay for drugs the same price as the nation that pays the lowest price -> best for big pharma to have "unique drugs" only sold in the US and nowhere else. Alt 1: develop/acquire such a drug, Alt 2: "adjust recipe" of an existing drug to make it unique.
@suspendedJoey@Longterms1 feel free to have a look at the substack post on Ascelia re the deals and partners. Are you aware of any other imaging agent with significant TAM in similar stage with FDA? New info much appreciated, always happy to educate myself on the topic.
@suspendedJoey@Longterms1 correct would be to call it an imaging agent, as it is not radioactive like gadolinium, that is 100% true. People tend to refer to the wider market as radiopharmaceuticals market (which it is part of).
@Longterms1 3. I have a feeling that ABG does not look at all what sort of deals (valuations) are happening in radiopharmaceuticals space in the US. Late-stage assets with immediate sales potential ...
@Longterms1 2. It's a big deal if you have a product which actually helps to avoid the potential side-effects of gadolinium. Awareness about gadolinium problems is continuously increasing. NSF is exactly something that guys like Kennedy would like to address.
Industry will realize that they need alternatives to gadolinium asap. Perfect time to bring Orviglance to the market -> a lot better position to negotiate partnership terms. Importantly, Orviglance production partner is located in the US - another box is ticked for the big guys.
China imposes export controls on gadolinium. 97% of all gadolinium comes from China. Most of the gadolinium is used for enhancing MRI images. We'll see how those export controls will work in reality, but this is a massive tailwing for Ascelia Pharma's product.
@Jaro_rogue Could it be impacted by Desmoxan (basically same drug, 1.5mg cytidine by Polish Aflofarma) being sold on Amazon for 20-30$? It's OTC in Poland and a lot of e-shops with global shipping. It's also OTC in Canada under CRAVV since 2017.
In the US alone, there are hundreds of thousands of people with kidney problems, who need to have a liver MRI, but canβt risk with gadolinium contrast. I believe the FDA should be very motivated to make this new contrast agent available to hospitals and patients asap!
I see more and more posts on X from people who have suffered from gadolinium toxicity (either nefrogenic system fibrosis or gadolinium deposition disease) after having had an MRI done with gadolinium contrast.
It shows that the awareness about gadolinium toxicity and associated risks is also increasing on patient level and this is a massive tailwind for Ascelia Pharma, who has developed the first non-gadolinium contrast agent for liver MRI with phase III successfully completed.
@LukeWolgram Ascelia Pharma:
1. Phase III successfully passed
2. Unique product with no competition in its niche & ODD
3. 800+ mUSD TAM
4. Sufficient cash buffer until FDA approval
5. Trading at < 30 mUSD
6. Clear near-term catalyst β partnership agreement to be signed. Multibagger