Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Timster you have posted here over 180 times in the last 30 days but most of the posts add zero value. Please can you only post relevant content here. This board loses credibility every time people post nonsense. Thanks
@BV I think for the clinical leads in these hospitals AVA6000 is an easy sell due to the lack of side effects alone vs Dox. When you also consider that as there is no placebo, straight Dox arm or randomised trial aspects they can talk openly about AVA6000 at such an early stage. This shouldn't be over looked imo as it is massively positive and patients although might get a choice the steer from your Dr goes a long way as you need confidence in them they know what they are doing.
When we consider the scope of fortnightly the patient population should increase not decrease. They can now choose patients from more indications in the first line setting not less. High levels of FAP are a requirement for this trial and P2 as it is expected to yield better results so best to screen low FAP patients out.
Obviously there is competition for trials but I hope to see we open up new sites in the coming months to support P2. At a minimum we need 9-12 patients for fortnightly only.
Lastly what does give me confidence that the patient recruitment isn't going as badly as people make out is this. They plan to backfill cohorts where possible to capture more data. So although they only need 3 patients per cohort to have 2 doses they will add more patients as and when recruitment allows. You don't do this if you struggle to get patients in the first place and going back to my first point do you want the standard version with horrendous side effects or the Prodrug version with little to no side effects.
I think the comms have missed a trick in recent months to spell out the significance of backfilling cohorts , allowing first line patients in C7 and now in fortnightly, along with multiple indications and the ability to dose multiple patients one day 1 . This should have been explained further in Dec perhaps this was deliberate. Time will tell. Key is in the detail.
AS said he doesn't intend to come back to the city to do a placing with PIs (because the last ones were leaked) and as I took part in previous ones I'm pleased to report the broker hasn't called. They have plenty of cash in the bank. More likely we see a commercial deal in the near term. Ignore the noise.
People overlook the fact that most of the previous interviews are done by people who actually know little about AVCT and what they are doing. This is obvious when you listen to the interviews. This limits the questions asked, the accuracy of the points made and the missed opportunity to ask more targeted questions. I suggest we wait for the output to make a more informed view but I think Myles will cover many points that have often been overlooked or even avoided.
Consillium might have been an option to host but frankly shareholders wouldn't know they even exist if there hadn't been an RNS saying they had been signed many months ago as it's unclear what they have been doing. Therefore why risk a party that potentially lacks the scientific or financial knowledge to host an interview and just cover the basic convenient questions which don't take us any further forward. I wasn't impressed with Gervais W a fund manger comments on Vox recently as he muddled the topics multiple times and got things wrong. Rather have an SME whoever that is put the questions to AS and use the time wisely. Judge the output not dismiss the opportunity is my suggestion.
Foreverwaiting personally I'm all in favour of having the interview with the CEO for the following reasons.
1. Myles knows this company inside out and is one of the few SMEs that understand much of the subject matter. Even if you ignore his opinions you only have to read his thesis to see the level of understanding he has is way beyond the comprehension of the average AVCT investor.
2. He has a large investment here and is therefore motivated to a positive outcome for shareholders (He didn't put himself forward for this but was asked to do it by other shareholders)
3. He already has a good relationship with AS so that should help AS be at ease unlike with an unknown interviewer.
4. Critically unlike Investor meet he won't burn precious Q&A time asking basic questions that can be learnt from the website.
5. Feedback on the wider commercial plans and opportunities will only be a positive thing for shareholders to better understand.
6. AS doesn't have to do this but is happy to do so which is very positive.
7. Given a choice do investors want more or less comms with the company? I can't see many going with the latter so every little helps.
Hi Keith, thanks for your detailed post. On your point below how much time would you expect these 3 items to take? I assume the second is already in play and subject to results but could come at the same time as testing results?. It's unclear to me what turn around time the exploitation application takes and is there a risk that is not granted?.
🦖This will enable in quick succession: a declaration of commerciality; signature of a definitive GSA with Afriquia Gaz, an application for an Exploitation Concession.
Thanks
Old trader - Stifel have been sat on the top of the offer almost constantly for days now. I don't like the fact they are the house broker and always seem to be top of the offer when the price is low. They sell into the bid smashing it down. Coincidence?
Bella the fortnightly dosing means patients get 50% more cumulative dose of AVA6000 in 12 weeks vs the 3 weekly dosing. This is huge. I can’t wait to see the impact of this on the tumours in first line patients. That is why they are doing this and like you said previously who wants this?
BV because of the mechanics ie protocol change, prepping for fortnightly C1 recruitment is from a standing start. This is not the case for any upcoming cohorts and given a patient only needs a month from first dose it’s much easier to schedule patients for the next cohorts. For this reason I don’t expect delays. In addition to that this is now focused on a much larger patient population ie first line patients and multiple indications and patients can be dosed simultaneously if available. I think these points are hugely over looked but will carry forward into P2 in most cases.
Lastly given the remarkable side effects profile alone and given this isn’t a randomised, or double blind or control arm trial I’m sure Dr Tap is not suggesting a straight dox treatment over AVA6000. Therefore he can talk openly to potential patients about the findings to date. This is a big advantage.
@NR11 about a week ago I confirmed this was the case. This was confirmed to me by AS on the 18th Jan. His words as follows. People can choose to believe this or not I don't care I'm just trying to be helpful and stem the disinformation.
'All is going well with Q2W in the US and we did say in the RNS associated with the data release that patients were being screened. We will update the market when all three patients in the first cohort have been dosed. That’s a more sensible milestone than first patient dosed because it tells the market more about when the cohort will likely complete.'
A few observations. We know they need a few weeks to do screening on patients and that has always been the case. We know that they are now recruiting first line patients from a wider number of indications not just STS. We know as part of the screening they are looking for patients with high FAP levels as that will lead to better results and likely better efficacy. I have no doubt the first patient or two was dosed sometime ago and the rationale to communicate when the 3rd patient has been dosed is sensible. We know each patient only needs 2 doses and 2 weeks observation periods for each dose therefore a patient completes in a month (they can have more doses but the next cohort can start after 3 patients have had 2 doses).
I think before each stage they won't be recruiting months in advance if the patient then can't start treatment asap. I believe 2-4 weeks before is the usual manner as I have asked AS this before. Now because they are able to cherry pick the ideal indications (which are likely to go into P2) and patients for the fortnightly trial as they want to ensure the best possible results by doing so the initial enrolment to this stage might have taken a little longer. However now that ball is rolling and they know exactly when the next cohort will commence I fully expect they have a backlog of patients ready to go into cohort 2. Essentially what I'm saying is due to the lag of the process ie admin, protocol change, getting product etc recruitment for C1 is likely more sensitive than C2,3,4 for the fortnightly. I'm sure we will find out soon 3 patients have been dosed. When we hear that all you need to do is understand in a month that 3rd patient completes their 2 doses and the next cohort can start. Critical they can also dose all 3 patients on day 1 if they are available a big change to the 3 weekly dosing. This is why they are confident of completing this by mid year.
@Bella - I agree I think this is a dynamic change to go from 3 weekly dosing to 2 weekly and missing P1b. I think it's very likely others are involved to facilitate this not just the FDA. I suspect we see a partnership or something of that level to progress multiple indications into P2 and address much bigger markets that just STS. Chemo with little or no side effects is even if efficacy was the same is a massive step forward. We expect efficacy to be improved pending more d
@Bella, re the Lilly phase 3 Lartruvo trial. Crucially....Guess who was involved with that trial?.....Dr William Tap! This is one of the unsuccessful trails he was involved with. The significance of this is as follows
1. He now knows AVCT can provide him a 'better version' of Dox in AVA6000 without the side effects
2. It is largely procedural before AVA6000 becomes the news standard of care for STS
3. His links to Lilly from the Lartruvo trial might well aid AVCT deals
4. The Lilly purchase of Point confirms they are already well aware of AVCT and now their previous trial lead Dr Tap is running the AVCT show in the US for AVA6000.
AVA6000 is the best opportunity for Dr Tap to finally get a drug approved by the FDA to benefit his patients. It's more targeted has less toxicity and a MOA proven in humans.
The Breadcrumbs are there. Dr Tap is one of the global leaders in STS oncology and he is representing little old AVCT.
JT this is a key point you make about accelerated/ breakthrough approval and completely overlooked by the market. This would ultimately mean revenue generating sales anytime from approval in 2024.
I understand the company are likely reluctant to talk about any of this in advance of a decision in order not to compromise it but they sure as hell will be aiming for this.
My personal view is that if this was your plan you would need to have the scale up capability already in progress. We know Fortnightly is required to confirm the RP2D, a dependency for P2. I think we see a big 6k deal long before P2 starts for this reason. No reason to wait 6 months when you could be organising this months before P2 even starts with the help of a partner. They you sit back and collect the revenues.
Starbright I take your point re conferences but they can play a positive role. For example there has been a complete lack of discussion on some key aspects following the Dec update. One of these is that the presentation still had multiple slides on preclinical data using PDX mouse models (we have seen many times now) as a reference point despite treating 40 humans. Why? We know only new data can be presented at AACR. Given AACR will be packed to the rafters with leading oncologists it's probably reasonable to assume that is a very suitable time to share the human models to the experts in their field. We know FAP in humans is a lot less than mice meaning it should have exquisite targeting in humans and the fact we still haven't found an MTD only confirms this. With C7 completion due anytime then allowing time for DQ to be complete April could be the perfect time to start talking openly about C1-7 in humans. I believe the company have deliberately been playing things down to ensure they can progress as far as they can through the time consuming trials as discreetly as possible each day collecting more valuable data. At some point that narrative changes. It's evident over the last few years that the awareness of Avacta's existence let alone what it is doing is still to a very limited audience.
Hi Pharma3, I'm glad you had a good day piow piow.. One of my favourite days, what a day out you must have had with AS. Was this pre or post Christmas?
Can you elaborate re your science comment and 'it's way more than anyone can imagine on this board?'...There are some well informed posters on here JT, Energy Shares, GMCC etc and certainly a few who are very good on the science so I'm curious to understand if something obvious has been overlooked by those SMEs or you refer to something else?
When you said 'big changes' soon what are your expectations here timeline wise and covering which of these... License deals, JVs, partnerships or a full blown takeover, something else?
Thanks in advance and I hope he tipped you well haha
@ Wearegroot - There are 3 unique aspects to Affimers and only one relates to DX usage currently. So I can imagine it's possible to sell DX with that one on license and TX keep the rest ie no negative impact on TX but perhaps value added to DX as a result. Lots of possibilities for Affimers going forward so best let them be progressed across the board
Bella some people can't be pleased whatever AS says but I'm happy with his latest view to RNS once the 3rd patient In a cohort has been dosed, then we know the maximum amount of time until 2 doses have been completed. Previously we wouldn't know this. After 3 patients have had 2 doses they can start the next cohort even if those patients continue to get treatment which is my expectation. We also now know all 3 cohort patients can be dosed simultaneuously on day 1 subject to recruitment which is a big change from Q3W where it dragged on and on and everything was 3 weeks apart. Given they have widened the number of indications for the fortnightly dosing and its now first line patients recruitment should be easier as more choice to pick the ideal patients. Therefore to complete 4 cohorts (could be less but they said 3-4) we need 12 patients dosed twice and that ticks the box to confirm the RP2D which is a dependency to start P2. Patients can continue treatment of course. It has taken time to get to this point now is time to stay the course and await the deal flow.
The market might one day care and given the market is mostly PI's the more knowledge they have the more likely sentiment changes. That is my positive spin in it anyway. Dismissing a positive doesn't help anyone.