The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
I mean the results are still on schedule for the end of Q2 and the start of the phase 2 dose expansion end of year followed by phase 2 efficacy straight after. I am sure the team have everything In hand. Commercialisation is still 2026 happy days.
Think it’s very clear from Avacta they are going to give the FDA as much data as possible probably way over the top for a standard phase 1 trial. You don’t obtain 10 biopsies from 9 different patients in multiple cohorts if all you are looking at is safety in phase 1. I could be totally wrong however don’t think other companies, have done that phase 1.
“Just because Amazon says my parcel has been delivered it doesn’t mean it will work when I open the box🤣🤣🤣🤣🤣”
Depends what was inside the box, if it was an item that was well understood over a period of 50 odd years that had a track record of doing exactly what you thought time and time again with a great track record let’s say a Staedtler pencil, that’s way less risky than some new technology that no one knows anything about, with many complex parts that could go wrong, let’s say a 10 colour ball point pen with flashing neon lights. 👍😜
From the RNS.
These emerging data clearly demonstrate that the pre|CISION? peptide drug conjugate platform is functioning in the way it was designed and is capable of targeting the release of a cancer therapy to the tumor.
👍👍
Well going by the Turner note which makes a lot of sense now, having had today’s RNS. The Phase 3 is for international opportunities. It’s clear they want AVA6000 approved by the FDA or the SMDC (back in Britain) Asap then partner at a way better deal. It’s also clear if the SMDC said it’s safe, the FDA will have likely come to the same conclusions and it’s only a matter of time before one of the FDA acceleration programs gets involved. AVA6000 is normal Dox and it is now officially deemed safe at 3.5 times the previous standard dose with no dose limiting toxicity. The bar is very low to replace the standard treatment it’s so toxic, we have passed over that bar imo and it’s inevitable the regulators will catch up imo. Only a matter of time now.
“Cohort 7 was the final cohort in the three-weekly study and even at this dose level (385 mg/m2), which is approximately 3.5x the equivalent standard dose of doxorubicin, dose-limiting toxicities were not observed and the Safety Data Monitoring Committee ("SMDC") has concluded that this dose level is safe. A number of patients remain on the three-weekly study at this time in several different cohorts.”
This could be the most significant paragraph in the entire RNS imo. We already know a cumulative dose of Dox has a significant impact on tumour disruption. The fact is the SMDC has now said 385mg is now “Safe” without observing any cardio-toxicity or dose limiting toxicity is incredible. Chris also mentioned a clear hypothesis of increased dose of Dox and increased efficacy within the FAP rich Tumour environment via the biopsy data. My understanding is 3w dose is only given because the body needs to recover from the toxins involved in chemotherapy. Based on the above paragraph (385mg safe) it’s clear we are going to get very near this level in the 2w study as well, however I think they will already have a optimal dose in mind based on all the data gathered so far. Pretty exciting stuff I expect several new case studies in the April update. It’s clear now in my eye's based on the data released today, they wanted to take this solo and all the way rather than partner up.
“To me it’s still not worth losing my shirt over”
That’s totally fine 👍👍💯 your opinion.
On a side note Avacta don’t care about the short term action on its share price, they are concentrating on the day job and have said they will give updates on the 3w/2w study late Q2. They have hired commercial expertise and seem to be wanting to go solo rather than partnering up. Dox is a multi billion dollar drug. So 18-20% dilution won’t affect the endgame that much if AVA6000 replaces it, when AVA6000 gets approved either by surrogate endpoint (PFS) or normal phase 2. This will be a total game changer for the company, you can either wait till FDA approval and buy in then or you can understand the research and be an early investor. Doesn’t put me up or down either way but try read the RNS’s first before trashing the company on a BB at least get the basics correct, would appreciate that 💯👍.
Use some common sense Touk, do you really need everything spelled out to you, patients are still getting treated outwith the cohort structures if it wasn’t working properly as expected on the biopsy data, this would be unethical and stopped by the patients Dr’s, (chemo toxic and deadly) good thing is, us as private investors can do some due diligence and research and make up our own minds if it’s working or not. That’s called getting ahead of the game (spotting an opportunity) we don’t actually need to wait till the FDA formally approves something to make a decision. Once this is approved you won’t be able to invest at these levels so that opportunity is gone. Pretty simple to understand. Don’t really get your negativity all the time though it’s very strange even when this has been discussed before.
Do you Read RNS’s touk?
10 tumour biopsies obtained from 9 patients in different cohorts have also been analysed in order to confirm the release of the active chemotherapy, doxorubicin, in the tumour tissue.
👍
Https://rtfilesprod.blob.core.windows.net/originalnotes/AvactaGroupplc_29_2_2024_FINAL_BGv2.pdf?sv=2019-07-07&sr=b&sig=BN91OTsRMnvpnlNT9nKTJytxw8EFWMClxKqLBtgcFzM%3D&se=2024-03-19T20%3A10%3A20Z&sp=r
So much confusion and hate on the BB at the moment, if you are new and thinking of investing in Avacta this 17 page PDF is a decent starting point for your research. Provided the link for easy access.
Find that hard to believe you only joined in May 2023. 🤣🤣🤦♂️👍 The share price has been here before, then it surged to 180 odd. Your obsession with Smith is hilarious, go take it up with the FCA if you are that bothered.
Form haha ok 👌. I go with what’s in the latest RNS which was Feb not like 6 months back.
“Read out of two-weekly and three-weekly dose escalation study data in late Q2 2024;”
Note the normal missing words that Avacta usually include “expected” or “anticipated”
They must be very confident on the above readout timeline, if not including the words I highlighted above.