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Lordloadsoflolly.
Nolupus on this board is nobbygnome on the ADVFN board, if you dont already know. Make no mistake they're are the same person.
IMM have not gone against FDA's recommendation. There's no evidence they did. Going straight into Phase 3 will still incorporate all of FDA's protocol as it were in Phase 2/3 adaptive study.
In a nutshell, in phase 2/3 they will stop briefly after 'phase 2' , report it, before moving onto 'phase 3'.
in Phase 3, they will do it in one go, no need of time delaying stoppages, therefore it will be quicker.
I will forecast the RNS will say,
"Don't panic Mr. Mainwaring"
If its bad, then you can kick the cat, throw your missus out of the house, headbutt your mother-in-law, rob a bank and smoke some weed. Otherwise stay calm.
There's a saying, 'keep your head when others are losing theirs'
Nolupus,
You should take a look at yourself in the mirror.
It is you who is trying to be too smart and too clever clogs.
The only thing brewing in Tim's office is the kettle. He reading his newspapers at the moment.
No on a serious note, let be honest with ourselves, we all know where this going contrary what some of us on here are saying. It just the time consuming delay getting there.
Where in the law constitutes a licensee must buy shares from the licensor?
How many do you know in the licencing pharma world have this happened.
What Alora done when they bought IMM's shares was a goodwill token gesture. A show of support.
Just what is Alora business, drug development or financial investment?
£663,000 left as of 31 December 2022, cash burn around £2m a year as you said lambo then IMM must be literally skint right now!
It is highly unusual in the pharma industry to fund raise when your down to your last penny or even totally skint! Fund raise are done many months in advance. So why haven't IMM already done so? What are they waiting for?
Come on lambo stop pretending you don't know. I expect IMM and the potential partner(s) for the CIDP indication for instance, are waiting for confirmation of the awarding of Orphan Drug Status as this will determine the CIDP value and subsequent licensing deal and with it the forthcoming upfront cash payment coming through IMM's letterbox.
It does not need to be the CIDP deal. It could be Lupuzor rest of the world deal or a deal on one of their anti-infectives. Any deal with cash payment will do it.
Now I posted this, IMM probably will shortly announce fund raise RNS!
.
Subcutaneous Injection was used in their original first phase 3 trial and all their previous trials.
Not long ago they had a RNS out stating the second future phase 3 would now be done by intravenous injection.
In the latest RNS, it now seems they revert it back to subcutaneous injection. They can't make their mind up.
If they succeed in their phase 3 trial Lupuzor will again have substantial price advantage over the competitors.
Avion's $25m more than enough covers the P2/P3 trial. There's no need for additional fund.
What is it you don't understand Nolupus?
(Sorry continuation from previous post)
But if the new adaptive phase 2/3 succeed and approved, Lupuzor will still have advantage over GSK and Astrazeneca if it has significant efficacy and no serious or none at all side effects.
I believed the chance of possiblity is high that it will succeed but nothing is guaranteed.
Reading on the last RNS update, it said the forth coming adaptive study will now be done by intravenous injection than by subcutaneous injection as it was in the previous phase 3 study.
Just wondering, if the previous phase 3 study was done by intravenous injection on the same lower dose that was used, as this method can get to the bloodstream more quickly, than we would probably have got significant efficacy and the endpoints required than we wouldn't be where we are now. The lower dose worked but probably should have been done by intravenous injection. Just a thought. That will be another argument.
For sure now, Lupuzor have lost its price advantage over the ones that are on the market. I can see the reason it was done by subcutaneous. It can be done by self injection by patients. This would cut out the fees charged by ' middle man ' the doctors, nurses. etc.
But if it is approved,
Nolupus
Blimey what a persistent pensioner. Just bow down gracefully and admit defeat.
No! wait, you're won! Hopefully this will shut him up. If you go to the kindergarten tomorrow, a kid will give you your gold medal around your neck.
Now can I get some sleep.
Nolupus
Whoever said Avion weren't satisfied with the data. Avion themselves?
Then why on earth did they first signed the licencing deal to fund phase 3 with $25m if they weren't satisfied with the data.
The recommendation came afterwards. It's now up to IMM/Avion whether to proceed or not. For the better or for the worse. We shall see.
The kindergarten opening tomorrow. Now make your way there.
I'm off to bed.
NolupusFFS, your so argumentative and sometimes full of crap. Always asking questions but never gives straight answers on this board. This is going round in circle. Go to a kindergarten they'll understand you.As you are retired, you live on this board. I don't. I got work to go to tomorrow.
Nolupus
What on earth are you talking about now. You are making it up as you go along. Avion doesn't want this to go to phase 3. Wtf?!
So Avion was the first to go to the FDA and asked to do more phases cos they love to spend more money.
I'm talking to a kid here. I need to go and take a headache pill.
Nolupus
Again I don't get you.
IMM/Avion can dump this recommendation from the FDA and start the original dose phase 3 now.
If IMM/Avion decide to take this recommendation, then it is their choice. No legal challenge against the FDA. The FDA have not withdrawn the original dose phase 3. The FDA is not forcing IMM/Avion to take it.
What is it you don't understand?
Nolupus
I don't understand you. What are you trying to say?
Nowhere in my last post did it say the FDA is forcing IMM/Avion to do this. As you said it is Avion/IMM decision as I mentioned.
Remember this is FDA recommendation to use higher dose. They are not telling IMM/Avion to do. It's a recommendation, the option to do it or not to do it.
After the original phase 3 inconclusive result, the FDA gave IMM the authority and allowed another phase 3 to go ahead. It is this written reponse Avion signed a licensing deal to fund and take it into phase 3, not phase 1 or 2.
The FDA cannot backtrack on this or it will be opened to legal challenge.
Now it looks like IMM/Avion will take this recommendation. Having higher dose does not mean it will be better. Neither the original dose or the higher dose will guarantee success.
The question is which one will have a higher chance of success.
With the original dose, we have a rich data to date. We know what went right and what went wrong. We are almost there to the finishing line with the second phase 3 we were about to start.
With this new higher dose, we are going backwards. We have no data on human subjects. Once we have the optimum dose level and move into into phase 3, we are going blind, fingers crossed and hoping it will pan out well. If it succeed, hooray approval awaits. If it fails, then what? They will have to resort going back to the original dose and the phase 3 what was originally planned. Years and money would have been wasted. With this original dose we know what we getting. With the higher dose it is thwart with danger of failure and carry a higher risks.
My personal opinion on this, if I was IMM/Avion is to run both the original dose and the higher dose concurrently in separate trials. As it were, get the best of both worlds. That's of course if FDA allows it. This would mean Avion will have to spend another £25m on top of the licenced deal £25m. IMM and Avion will have to renegotiate the licencing deal and to compensate this Avion now take the whole worldwide rights to Lupuzor and IMM will now receive higher royalty, say, between 20% to 25% in return. Just my opinion on this of course.
I still don't believe people here are still contemplating whether FDA would approve phase 3 or not.
What is it that you lot don't understand?
After the first inconclusive phase 3 trial, IMM held talks with the FDA and the FDA gave authority another phase 3 would be allowed pending design protocol.
On this account, Avion signed a licensing deal with IMM to take and fund Lupuzor into second phase 3 trial
Numerous RNS state Avion will take and fund phase 3. Nowhere does it state "if FDA approve phase 3, Avion will fund future phase 3".
Correction on my previous post,
exacting should have read exactly.
Alternately should have read Alternatively.
Blamed it on awful predictive texting.