Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Read RNS 21st March:
"The data from the expansion study will be used to inform the optimal choice of a single orphan indication for the Phase 2 efficacy study which will follow on immediately."
The expansion is indeed in multiple indications, but from that only ONE will be selected for phase 2
"AVA6000 is not going to be a deal maker...it's a data miner for Avacta who will see it through to commercialisation."
Why not? After all, Avacta is only trialling AVA6000 in Phase 2 in ONE orphan indication as stated. That leaves a whole host of deals to be done with partners in other indications in tandem.
The 2 weekly will identify ONE indication as the most susceptible to AVA6000, which, presumably, Avacta will pursue. This does not preclude the 'drug' 'working' in other indications - merely that it might not work as well.
Question then is, what does Avacta do with the other indications there are signs of efficacy in (that may not even be orphan)? Just sit by for 2 years until they have approval for STS (pending phase 3), for example, before selecting target 2 for another orphan indication phase 2 etc. etc. Somehow I don't think so.
I think it is not outside the realms of possibility that AVA6000 will be partnered. And fairly soon.
J_t & B2HS2L - seems we are talking at cross-purposes. I am not disputing that STS and all its sub-types will be the focus of the does expansion. I am pointing out that Avacta has not (since at least 28th Feb RNS) formally identified STS (a single orphan indication/ODD) as THE "single orphan indication" they will definitively target in phase 2. Options remain open according to their own words:
February 28th RNS:
"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."
March 21st RNS:
"The data from the expansion study will be used to inform the optimal choice of a single orphan indication for the Phase 2 efficacy study which will follow on immediately."
Again, I might be missing something glaringly obvious, but from the above it remains possible that STS will not be THE most receptive target of AVA6000 following dose expansion and Avacta would like (under the guidance of the FDA) to keep their options open as to a definitive target for phase 2.
B2HS2L - Soft Tissue Sarcoma is the catch-all ODD for all the different sub-types unless I am mistaken. This means that there is at least a possibility that Avacta will be going after a completely different Orphan designated condition for the phase 2 after the dose expansion study. Why this has become a possibility is what is not clear. Perhaps they are keeping their options open in case greater efficacy is witnessed in another high FAP cancer type, which would be sensible in a lot of ways.
To come back to my point regarding deciding on the 'single orphan indication' in the latest RNS. If, as JT has pointed out, Avacta is looking to choose a 'sub type' of STS , why would the Company not say Phase 2 will be in STS since STS as an ODD is not split into subtypes as far as I can tell? Instead, what they said in the 28th February RNS was:
'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.'
So, again, although it is HIGHLY likely the Phase 2 will be in STS, we can still not definitively say that is the case because in March 21st RNS it is stated:
'The data from the expansion study will be used to inform the optimal choice of a single orphan indication for the Phase 2 efficacy study'
What has changed here? Are we waiting for AVA6000 approval in other Orphan Indications prior to Phase 2? Why the ambiguity if not?
Aren't we ignoring the fact that STS hasn't even been identified as the single orphan indication target for the upcoming phase 2 study? In that same paragraph of the latest RNS, Avacta refers to "future efficacy studies" plural. I get the feeling that a partner for other indications for AVA6000 may be being lined up.
Do you want to let this guy know then? Seems he hasn't quite grasped what you have.
Lee Cranmer MD, PhD, FACP, Curtis and Elizabeth Anderson Endowed Professor in Sarcoma Research, University of Washington and Professor and Director of Sarcoma Oncology, Fred Hutchinson Cancer Center, commented:
"I am encouraged by the initial data with AVA6000 in the Phase 1 trial and look forward to working with my fellow investigators and our collaborators at Avacta to understand better the optimal dosing for this novel approach to targeted cancer therapy."
What is so difficult to understand about the word facile? I'm not trying to do down the science to date, I'm simply pointing out that just because someone says something is "working" as designed to in an RNS doesn't mean that it has been proven scientifically, otherwise why are we bothering to carry out further studies designed to show exactly that? I bloody hope "it works" as I've got 200K shares underwater right now. It works when it has approval and surprise surprise, the share price is higher than we all paid.
One day I'm accused of ramping and the next of FUD. I see how wyndrum and Touk feel now getting shouted down for stating the f'ing obvious.
I remember one Professor Sylviane Muller PhD of ImmuPharma once saying "it works" and then, well, it didn't. That was in phase 3. Timster, how'd you like that post yesterday calling you out for being a t*at getting so many recs?
Energyshares, me too:
One has 3 options to believe based on this info: pure chance, a downright falsehood or AVA6000 is working as intended (at least for this patient). Said patient is one of at least 5 we have been given snippets of positive information about. Snippets because the full data is to be released with the maximum impact and not before at the AACR.
Similarly:
https://www.youtube.com/watch?v=9weuscZgwKM - 19 mins in (posted yesterday by I forget who, sorry)
As alluded to here, they (the community within which Tapp et al., are operating) are having to be incredibly tight-lipped until (someone’s) data is released in the appropriate forum.
So, scientific mutterings are guiding us in the right direction, but what is not are the actions of the BoD and the 0.50p raise as is pointed out ad nauseum by wyndrum et al. Again, only a few options here:
1) science isn't working and the raise is a last ditch attempt to defraud the market and run off into the sunset with the cash
2) Avacta getting spiv mates in on the cheap because they’re just a dodgy outfit
3) there was a heavyweight European healthcare fund (such as the one identified by Bella) calling the shots price wise on the proviso that they would support the remainder of Avacta's clinical activity prior to commercialisation - a strong position in the face of opportunistic big pharma, one would have to agree
4) in spite of the data, the market was just so difficult this was the only price that worked (i.e. we were valued at at the time)
5) I've over embellished or missed something, but someone is sure to point that out (cue wyndrum…)
Take your pick from the above and make your call
I saw this to55er the other day.
He actually says something interesting, however. He said he bought in because the price was at a "more than 30% discount" from where the shares were trading at. He was just a late comer to the party and invested because that sounded like a good deal at the time as the real target of the raise had agreed the price already. It was a cash grab rather than a targeted approach so good for Alastair.
Gje306 & Livedataaccount - these points were covered in the post.
The didn't want PIs or just any old IIs - specialist healthcare funds were the target, for obvious reason. Hence Alastair saying it on film and reiterating rather specifically in the RNS.
As for the confusion regarding what is what with the trial, perhaps it's because they haven't yet decided with the relevant parties or regulator/s what is and isn't to be targeted and therefore required from a regulatory standpoint.
Alternatively, it's all malice and you'd better sell up.
PL75, they couldn't "sell the story" because no one wanted to buy it. Alastair has been scratching around down the back of the sofa for at least a year and no one wanted to invest. He said it himself, Avacta was considered too expensive for what it was compared to peers. What "you'd have preferred" kinda sums up the attitude of the average Avacta holder, doesn't it. Entitled. We're all responsible for buying in at inflated prices based on Avacta's boosting and our own greed for the past few years and when it came to the market we needed it simply said: "na, we think it's worth around 70p a share, but we'll take a discount at 50p and give you the dosh, take it or leave it."
Not going to disagree that Alastair has been hapless, to put it mildly, since I've invested so no defence given here. A shambles.
Ophidian has suggested on X:
“My guess is cohort 5,6,7 data have crashed this realisation and by extension that of the entire pre|CISION platform into an unsuspecting AVCT BoD who have now dramatically (but correctly) torn up the old plan and now look at the behemoth of an opportunity they have in their lap.”
I too (now) believe that the goal posts have been moved as a result of the FDA reviewing the data thus far and broadening the opportunity for AVA6000 to encompass multiple new Orphan indications (and who knows what else) yet to be divulged. The delay with the commencement of the 2 weekly study and the ongoing radio silence is, I feel, a result of the necessity to redesign the parameters of all clinical activity henceforth for submission to the regulator/s. This, rightly, should take time. Time we hadn't been told to expect. And money. Money we weren't told we required so soon.
AACR will be the watershed after which data will be there for everyone to see and all bets will be off. Securing appropriate (specialist healthcare investor) funding rapidly, almost regardless of price, was more important than it would have been otherwise, in order to strengthen their hand in the perhaps expedited negotiations or to ward off lowball bids for the assets/business.
Those baying for blood can call it “malice” if they like, but I put to you that Avacta’s actions of the last couple of months are far more adequately explained by “stupidity” or, as I’d rather put it, “ignorance of the opportunity” that has now presented itself given the overwhelmingly positive data they have received. We are victims of our own success, one might say.
If this post ages like milk, so be it! Time will tell and the AACR is fast approaching.