Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Bella, fully agree... In order to sell the platform as a whole, licensees might not want AVCT to take shortcuts but want to base their decision on a full trial set-up, including phase 1b. Ignore Icecool. He enjoys being deceived, sticking his head in the sand.
What is the Optimus project?
BTW, from the RNS:
The dose expansions are expected to begin in H2 2024 in the USA, followed by the Phase 2 efficacy study, subject to funding and FDA approval, which the Board considers to be a major value-driving event for the Group. The dose expansions are expected to be in several orphan indications including soft tissue sarcomas and the selection of these dose expansion indications will be informed by data from the ongoing two-weekly and three-weekly dose escalation studies.
Each to their own interpretation. I just hope they will sell DX by latest Q1-2025 to increase the cash buffer... even if they only fetch 15Mio GBP (massive loss)... buying time to progress AVA6000 inhouse for as long as possible is key.. Staying in the driver seat.
Again, misleading... these are the indications that they select for the dose expansion phase... out of which they select one phase 2 indication, which will initiate the actual phase 2 (Q2 2025). Again, interpret as you wish.
Look at the Turner Pope Graph, "dose expansion phase", look at the RNS, "dose expansion phase"... Google "dose expansion phase". I am going to stop to try opening your eyes. Believe what you want to believe :-)
And yes Wiggly, you might be on the ball there... someone screwed up or assumed it would be ok to drop phase 1b... That might be the reason for the CSO and CDO departures.
No shortcuts anymore. Follow the standard trial regime, take the financial hit and keep going. As long as good results come out of 2WC and phase 1b, I am ok.
Now you are sticking your head in the sand. Final indication of phase 2 is selected in Q2 2025, coming out of the dose expansion. They are trying to not make it too obvious that phase 1b is back... It is misleading and I don't understand why they are not more upfront.
Phase 2 starts effectively in Q2 2025. That is the delay... on the other hand, in return for that delay, you have additional data: Phase 1b and 2WC data... so well... if that data gives promising results, at least there is some value in return for the delay.
Ready my message and look at the graph... They start phase 1b this year... dose expansion... they just called it "dose expansion leading into phase 2"... very misleading... Google dose expansion... that's phase 1b.
It's very simple... they had to reinstate phase 1b... Why? Maybe FDA, or maybe they noticed from partnership discussions that there is value in not skipping phase 1B, for the platform as a whole. That for me is the question... why did they reinstate phase 1b?
Exactly my point in the post I made... Phase 1b removal was apparently not approved by FDA and had to be reinstated. They did not count on that and did not have the cash buffer to deal with that additional trial-phase.
To all,
Remember last year when they announced they would remove and replace phase 1b by the short bi-weekly study, resulting in an expedited timeline and resulting cost reduction? Looking at the Turner Pope graph, they sneakily did call it "Dose expansion into phase 2". A few milestones:
- Q4-2024: Phase 2 Expansion cohorts (this is where dose escalation phase starts --> typically called phase 1b)
- Q2-2025: Selection final Phase 2 Indication (this is where the real phase 2 starts)
- Q2-2025: Final Phase 1 data (not Phase 1a, but Phase 1... incorporating Phase 1b - dose escalation) & AACR for AVA6000 Phase 1 (2w and 3w)
SO WHAT HAPPENED:
- They did not get clearance to remove Phase 1b by FDA
- Next to the newly instated bi-weekly dosing, they had to reinstate Phase 1b
- Resulting timelines slipped to even more than before (not just Phase 1b, but on 2 weekly dosing study)
- Ongoing commercial discussions based on reduced timeline and solid cash position now compromised since a year added and avacta not having the contingency cash to absorb
- RESULT: Scramble for cash to cover extended timeline and addition of Phase 1b
MY POSITION:
- as long as the science keeps delivering, I stay put. the addition of bi-weekly dosing on top of Phase 1b might prove to be a blessing in disguise if it proves to improve effectivity.
My two cents
i for one am even relieved they managed to fill the subscription at that horrendous price level. if not, we'd be really in the ****ter.
i believe in the tech, but am shocked how so many rns-broker words on the trial still manage to leave us guessing what the trial plan really is? phase 1b, dose expansion, phase 2, phase 3... too much unclarity hence pi's second guessing... on purpose?
Fiona and Neil were pushed out... Did not leave by own accord.
The science continues to perform well. So far, C7 still no signs of MTD. Finally, the hair in the ointment was that reinstatement of Phase 1b, adding to cost and time. That's the reason for the raise and stalled discussions. Now they are funded, they can go-ahead and pick up discussions at a later stage with more data in hand.
Ok,
General Oz his account is 2 days old and only posts AVCT. Please ignore. Now he tries to challenge the science. The science works better than expected:
1) C7 appears not to give an MTD = MAJOR
2) The reported patients continue to do well. All C3 (the 65% reduction) and C4 (halt of progress in 3 of which 2 had rapid growing disease)
3) From what I read is that bi-weekly is still recruiting but will heave read out within several months (together with C7, confirming no MTD)
What is new:
1) that then indeed a dose-escalation study will take place
2) will incorporate additional types next to STS = Great
What does it mean:
1) Confirmation over coming months of no MTD found in C7
2) One can expect over coming months continued positive trial news from bi-weekly which should increase efficacy
So no news-dry vacuum but continued hopefully positive news on the technology. That should be the foundation. Now up to management to try and flog DX and use the trial news to lure in license partners...
What do you people think is a realistic shareprice to close the year of with assuming:
- Phase 1a data has no surprises. AVA6000 is safe and has clear shows of effectiveness
- Bi-weekly dosing study started
- No license deal yet
It is easy to get carried away, but what is the highly realistic minimum price expectation for end of year? Mine: 2GBP (obviously having higher hopes)