Member Info for RorkesDrift

September. Definitely September

If you don't have a licence why would you promote to oncologists. Added to which it is not allowed

I'm not convinced it has to be licensed by Takeda. Some marketing advantages but plenty of companies that fancy the potential profit. Takeda would cannibalise their own sales and thus the "marginal" RoI would look different. Hopefully a bidding war commences based on the future earnings for all potential suitors

Have to say whoever spotted this last Friday whilst market was open deserves all the. Recommends and more.

At the risk of adopting 2+2 = SP(any number you like) then there are other implications

AVA6000 "active" is dox. The delivery mechanism (precision) is new. Therefore it may be possible for regulatory authorities to take a view that the standard phase I,II, III approach can be modified. If Avacta can demonstrate liberated dox is in high concentrations at tumour site whilst having low systemic exposure then the trials could be accelerated - for example phase II and III being merged. IF we get orphan drug status this may support such a move.

Plus expect Dx to pull something our the bag. Remember September is always magic month for Avacta.
https://youtu.be/Gs069dndIYk

Agreed but no way of stating it as fact - so woukdnt over interpret it. Thinking that the trial is a pk study so actually low numbers needed and STS patients included

For me I interpret as Avacta confident enough to submit - after that the content is secondary. Regulatory team seem stacks better.

Next thing will be Europe.

We could paint some pictures. The point about orphan diseases for orphan drug status is well made. Several patients have received Ava6000. Of these there may have been a patient with a rare, orphan disease who responded well. Avacta then use subset of data from trial.

Alternatively there is a realisation within Avacta who have had to improve their regulatory team in the last 12 months, coupled with insights from a range of new external experts that orphan status is on the cards.

Takes a lot of effort and resource to pull together a filing. One of the resources is time. All in all Avacta wouldn't want to repeat the effort so absolutely this step is positive. Hopefully it includes some human data. Hopefully.

I am thinking you can apply for orphan designation without clinical data. If you have decent scientific rationale and preclinical data then it could be assessed.

Unlikely they would submit from a trial part way through but application starts clock ticking. Could add to it say 60 days from now :-)

AS also said no need to fund raise three weeks before he announced a fund raise and the fact he had been in discussions for over a year.

AS has also said all options on table.

The milestone payment first second candidate could be linked to progress with the first was my point though. Unusual but would enable risk for partner to be reflected yet bring clarity to Avacta financing. This would benefit SP and accelerate Avacta

My own view is Avacta lack the Marketing clout to establish Precision as a therapeutic approach. Far better to let a big hitter do that and piggy back it with the next wave. I expect a co-marketing deal at the very least but maybe a US: Europe split. Lots of examples out there. Just my opinion and not precious about it. The options all arise from the inherent value of precision.

Could hedge by using milestones e.g. first patient enrolled in phase 1b

Using RECIST 1.1 for some secondary measures.

https://recist.eortc.org/recist-1-1-2/

The trial is not designed to look at efficacy. Simple read of clinical trial info shows that patient inclusion criteria, primary and secondary end points are not geared up time this.

The trial is primarily looking at the pk of ava6000, liberated dox and the leaving group. You might get a hint of efficacy especially when we consider biopsy data but nothing to hang your hat on.

The dose increases are much smaller than the 6x used in mouse that resulted in equivalent systemic exposure. Thus the P1b and subsequent P3 might be to give only slightly higher doses - (no-one can say 160 is the right dose without looking at data ) but more frequently. Aim being to have max efficacy at site of tumour (again only possible with access to data) whilst limiting systemic exposure. Higher then this is pointless, lower is sub optimal. Hence the latest DE and the point of the trial

Snap

At the time I couldn't work out why the Avacta science day was timetabled for November. Why wait that long.

I'm guessing that there will be an investigators meeting alongside it to discuss P1a results and prepare everyone for 1B. Transatlantic flights already booked so that US community included. Ideally would have done alongside big oncology meeting with sponsored symposium but you cannot have everything. If I was a trader I'd be buying before this meeting and closing any shorts.

I've just built cinema room. Second on list is Top Gun 2 but only after I've watched that film about the two nuns and a vicar visiting Amsterdam

I'm dwelling on it now.

I'm thinking licence out Ava0006 now with big upfront and partner carries the development cost.

This would derisk the velcade - basically the development piggybacks first product. Partner marketing muscle establishes precision in market place. (Bit like Intel inside approach)

Ignore Takeda and launch son of velcade ourselves thus keeping all the margin.

AS saying the opposite but maybe a negotiating position.

Takeda then hit back with £200........

There is discussion about where Avacta secure money from - cash runway is looming and this has given shorters a gap to exploit. However given today's news the Board have strengthened their other options

1. Most obvious place would be existing licensing deals with LG and Daewoohoo. They are due to pay milestones but maybe not so much. Avacta could bring forward payments or extend scope of deal - terms would meet the needs of both sides.

2. Licensing of two precision products. Whilst they want to hold onto one the choice to let the both go is there. The deal could see the cost of bring them to market and establishing precision bourn by partner. Extends eventual pay off to us but actually might just prompt TO

3. Debt. Given favourable P1a results then debt might be easier to raise and pay off. This would avoid dilution and may be a good short term fix. Would see conversion loan at £today +50% put shorter to flight

4. Nasdaq raise. Could be the best thing especially if after P1a results and announcement of Takeda / Another licensing / Development deal

5. TO - someone offers £200 ex-China and we all head off to Wheatherby Whaler wearing shumpers and natty beards.

Sad as it is the trial is about the pk of the drug not the efficacy. It would be good to think that if a patient responded well to the highest doses they could receiver more. Companies can provide unlicensed drugs on compassionate basis but clinician would need to take responsibility - including the Trust would need to sign off. As long as patients are fully informed it could happen but not be part of the trial. Far more likely in P1b

The dose of traditional dose is set by its lack of tolerability not its efficacy. Presumably bigger doses which have a bigger response (efficacy) but you cannot go too high because if you do you knacker the heart. What is needed is a drug that is as effective as dox but can be used at the top of the dose response curve without damaging the heart.

Oh hang on....