Member Info for dallo

Andie
It is brilliant punt for Alora/Avion committing up to $25m for a potential Lupuzor income in US of perhaps $100 to $150m per annum.
( based on US Lupus market of c 50% of total world market of $3b even though US sufferers account for just 30% of world's total Lupus sufferers of 5m and a market share of say 8/10%)
Alora/Acella/ Avion know their way around FDA submissions so maybe the chances for Lupuzor may be higher than 42% .

Nolupus
There is not much to do for these guys anymore..Avion running
the regulatory pathway for Lupuzor . Incanthera is a passive investment with
some potential for good returns and UreKa Sarl probably will be sold at the right price.
Chairman Mao Tse Tim is probably self-isolating and Zimmers gone to Switzerland.
Dimitriu holding the fort and minding the phones.
Ultimately everything hinges on Avion now and IF IF IF they get approval for Lupuzor in a few years
from the FDA then I suspect they or someone else will take out IMMU and that will be that.
If the dream comes true then IMMU could have annual royalty and other income of over $50/60 m
until generics start to eat into its lunch so IMMU could be worth $250/350 m in 2/3 years if everything
goes swimmingly.
Fun back of cigarette pack forecasts below;
Odds for Lupuzor getting to the market .... SPA approval (70% ) X Phase 3 Success/FDA Approval (60%) = 42% .
Seems just about right but I am sure that Nolupus will have
some thoughts on the matter.

Nolupus
We both been here a long time but such an
moonshot statement is bizarre by any standards.
I am surprised that Dimitriu allowed it and commented on it as usually he is quite conservative.

Nolupus
I am being sarcastic.
Of course, I don't believe the FDA would give Avion the nod.
But what inspired them to go for conditional approval.
Maybe they are on the wacky tobaccy.

Nolupus
Indeed..........For "nod" please put "vague positive feedback from FDA to tentative soundings
from Avion" on the possibility of conditional approval.

Nolupus
I fully agree.
I thought Avion( and Immu) would be more than delighted to get an FDA approved SPA say based on Lupus sufferers who are Antibody positive ( 60% of total Lupus population) and not be pushing for a moonshot gamble on obtaining conditional approval immediately for Lupuzor UNLESS THEY GOT A NOD FROM SOMEONE IN THE FDA.
Nothing would surprise me anymore particularly with IMMU .

Yes I have
If it a follow up meetin to an original refusal of a SPA then we should been informed .
Definitely then the height of cheek of Avion to request a conditional approval having been told to get lost by the FDA....like asking your neighbour for a new football because your old one was burst when you kicked it through his window.

The seeking of a conditional approval for Lupuzor from the FDA during Phase3 would be very cheeky indeed of Avion in advance of anything other than an expected positive meeting.
It would be like asking for your football back after you kicked it through your neighbours window.

Nolupus
I have already examined the reasons for a Type A
FDA meeting and I am not sure under which agenda heading the discussion is being held.
It could be a follow up to an original application , stalled drug situation et al ..we haven't been told but obviously centres around the granting of the SPA.
I wonder what % of FDA Approvals are in favour of US companies with facilities and employment in the US...I am sure the FDA is totally impartial.

Adam
Please read RNS
You are referring to a request for conditional approval for Lupuzor while Phase 3 trial is ongoing.
This is additional to the SPA and would be icing on the cake and that is why they are cautious.

The SPA is important as the FDA wants to give firm guidance to applicants embarking on Phase 3 trials to improve the chances of a successful final approval which for Phase3 is 60%.
The FDA approved c 50 novel drugs last year.
Just under 10% of all drugs that enter clinical trials (phase 1 onwards) get final FDA Approval.
The SPA is structured to allow for a more focussed and clearly defined trial with firm endpoints .
Once agreed with the FDA it is extremely difficult to change the parameters of the SPA so this is why the meeting on the 4th December is very important as the company ( Avion) can state it's case and establish the parameters and endpoints for the trial.
An agreed SPA should reduce risk of failure of Phase 3 trial and allow Lupuzor to be one of the 60% that get FDA approval.

Once the liquidity issue on the Nasdaq is sorted the SP will motor.
It may require Invesco to offload but I am sure Daphne knows what she is doing.
Otherwise pointless having a listing on the Nasdaq.
Still a great buy so let's see what happens.

If you are watching the lunacy in Covid 19 stocks which has drawn in the gold rush punters and driven some AIM Pharmas to stratospheric valuations on hope value only you can see how undervalued Ethernity is in a real trillion $ market with excellent techology .
If we reflect on that for a moment you be more than reassured.

I don't think there are many loose holders around and with tight liquidity in such a tiny market cap company the movements can be savage.
That's why I keep harping on about positive newsflow which should sent the SP back to where it should be.
Nibbling by new investors drawn to the story will drive the SP by 15% in a day on a 100000 shares bought volume..ie up 3p.
We all want the warrants exercised and SP back to at least 40p even without major news.
Watch tomorrow for signs of a rerating and more newbie investors.

News referring to ACE NIC-100 and Fibrehome , TietoEVRY et al and it is a rocket ship to £1.
It has been a year since Fibrehome tie up announcement so hopefully we are getting nearer.
Watch SP and particularly volumes to ascertain whether it is just newbie buying or something else.

Tracy
There is a hint of imminent news in today's SP rise and volumes.
A further spurt tomorrow may just confirm it.

Syste
Those who took part in the placing on the 13th July 2020 ( inc Directors) got warrants of 1 share for every 2 subscribed to be exercised within 12 months from date of issue when SP hits 30p and 40p

Interesting day with volumes picking and not driven by me for a change.
The exercise of the warrants is getting closer
with a 1st trance of funds of £650,000 possible if SP hits 30p ( for 5 days) and a further £975,000 if SP gets to 40p assuming all warrants are exercised
I am talking to my broker regarding the issue of a TR-1 declaration this week .
ATB

Correction
Average cost per patient in Phase 3 is BETWEEN
$30000 and $75000 ( Survey in 2016 for US Department of Health)

The average cost per patient in a Phase 3 drug trial is $75,000 and the average number of patients is 225 .
As I said in a previous post I envisage Avion having a 300 person trial which will be significantly larger than the last Phase 3 trial by Immu.