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Thanks but this is different- helium was because it’s unsafe in the MRI. Polx hasn’t had a safety read out - just manufacturing. Remember it’s been in hospital on research permits for 4 years and working fine
With COVID landscape and dire need for imaging in the coming years, MRI technology will need to be pushed through. Look up Bracco imaging and Linde gasses - that is a major shareholder and the gas supplier. This is some technicality poorly communicated to the market - just watch!
The product hasn’t been rejected - the drug works. So they can put the drug in a different machine - sure. However - what they will do it’s reapply on the same drug and technology with replies to the FDA comments on manufacturing. That’s what you will look out for as developments. As it stands at the moment, they don’t need any other products. Xenon gas has been around for many years and is totally safe.
They were too confident with FDA. Probably whoever was on their committee is just being cruel on a technicality. They got a slap on the wrist and share price has taken a hit on the back of that. The technology works - it’s safe and it has positive data read outs whole way through. This isn’t like a therapeutic failure where the technology just doesn’t work. It’s a manufacturing delay - that’s it!
Some technicality on the NDA somewhere with the manufacturer. Bracco imaging can do adequate Due Diligence on MRI technology - and they have put in £5m. Linde have been manufacturing hospital gases for 150 years, and can absolutely provide a hyperpolarised noble gas - something that has been on the market for years.
It is a technicality somewhere stopping immediate approval. Everyone was extremely confident of approval and IMO something had an oversight somewhere and it’s failed on a technicality.
The company will issue statements explaining. The real issue here is that the technicality was not communicated to the market at all…
No, the company went thru Hatch Waxman which is hardly ever used. The technology has been in hospital used on children for 4 years. It’s safe and efficacious. It will be some technicality somewhere - technology will be 6 mos delayed to market and that’s it
Avacta is not being accurately perceived or understood currently in the market. Avacta is a therapeutics company developing Affirmers for novel immunity-oncology. During Covid, the company realised that it can also offer its Affirmers there, because Affirmers (compared to antibodies) have superior functionality and are easier/cheaper to manufacture. Avacta is a strong company on both its therapeutics and diagnostics. Even in Covid, we are now facing a long term presence of the disease. We will always require antibody testing and we will always require novel antibodies for the development of immuno-onolocy. There is absolutely no reason to sell this stock. The only selling is coming from gamblers, not investors. Those holders don’t understand the stock. Those holders will clear and once they do, Avacta can be in peace to achieve its immense upside potential. It is a therapeutics and diagnostics hybrid on the precipice of success in viral diagnostics and cancer therapeutics. DYOR, but make sure you understand the BUSINESS not just the price pattern in the last few months. Then you will understand the true value of this company
Remember that it is against other approved therapeutics, not therapeutics currently in the FDA approval process.
The market is large enough to accommodate everyone - de novo and FDA approval shouldn’t concern you.
In terms of the company not replying, they just went through the IPO process. I would imagine they are getting to grips with new found responsiveness to a larger shareholder base.
Price has slipped on low volumes in this choppy market. Just like we saw revolution beauty getting smacked on its IPO this week. Happy to see stocks still responding to news flow - not all bad.
GIC has a good number of milestones coming up with the FDA and IMO that is a series of inflection points. When compared to peers with validated technology like ONC at 180p - hopefully milestone announcements will pick up the market cap to where GENI should be.
Considering the NHS just wrote that genetic testing should be general practice for certain cardiovascular diseases… hopefully GENI latches onto that. An in road as genetic testing provider to NHS cardiovascular would be absolutely transformational.
LLAI is no competition to ONC. ONC is an auto antibody cancer detection test, whereas LLAI detects circulating tumour cells. LLAI will be able to tell the doctor - if they identify nodules on a CT scan - that there is cancer in the blood . LLAI would be around stage 1 cancer if validated through clinical trial.
Far more specific than LLAI, ONC will be able to tell the doctor what kind of cancer (lung) is in the blood by the body’s immune response to the cancer. It is 1) earlier stage 2) more specific 3) in a far more advanced stage of commercialisation with the support of all the Pharma clients on its immunoinsights platform.
There is no comparison on the technology. The confusion between ONC, LLAI and Galeri is factually incorrect - full stop.
DYOR
It cant be Grail. Grail will struggle to meet efficacy targets on lung cancer. Maybe it can detect stage 4 cancer via Circulating Tumor Cells, but if you have stage 4 lung cancer you probably already know.
I doubt Grail will detect stage 1 like ONC's tech can. Grail is just a screening test to detect CTCs in the blood and it's very non specific, so cells could come from anywhere in the body. ONC's test detects at an earlier stage of cancer and it can direct the diagnosis/treatment to where the cancer is located, i.e. lung.
ONC shouldn't be at placing price. There's no competition from Grail or any other CTC providers in my opinion. Completely different diagnostic outcomes, and the market is colossal so all diagnostics can work together in it anyway.