Member Info for Supermobileman

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 The FDA have not withdrawn the original dose phase 3.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.

IMM had a fund raise of £3.55m back late December 2021. The end of year result left as at 31st Dec 2021 was £1.6m. The question is was the £3.55m came after the £1.6m result which would mean £1.6m + £3.55m or the £3.55m has already factored in which would now be £1.6m is what left.

For the sake of argument, let just say it is exacting what is left £1.6m. If IMM is burning through £3.5m a year as someone said on this board and we are now half year 2022 then IMM is almost literally bankrupt right now. If your going to fund raise you don't wait until your down to your last pennies.

So why haven't IMM done so?

I'm not saying they won't. They may will do it in the next few days or weeks.
Alternately of course, is the licencing deal they are working on, on their CIDP. Normally for a drug awarded with a orphan drug designation depending on indication and is phase 3 ready, can command an upfront payment of $50m to $300m and royalty of 35% to 50% on sales. I'm not saying IMM will get that. After what happened to IMM's Lupuzor on their first phase 3 trial potential partners will be weary offering anything near that and according to IMM there two remaining suitors currently in discussions. If this was IMM (CIDP) first drug phase 3 ready (let say they never had Lupuzor) then this is the licencing sum I would expect.
As for fund raising, I expect they are holding out because of the CIDP deal and it will not be needed. But if they do fund raise it because the deal have not concluded in the timescale they hoped for and will do so to tie them up until it does.

"Probably coming soon..." similar analogous to your namesake Aventador...., bullsh.t

Stop telling load of lies.

Stop scaremongering about the £700k payment lambo222. The £700k can be paid back by issuing in shares. And some of the cash burn rate last time around was due to paying off the directors who left.
Try harder to deramp this you may get your buying in price.

If you believe that's the case then what are you doing whinging and whining here on www.lse.co.uk. Give the Serious Fraud Office a call. Here is one of their phone numbers 0300 123 2040. They will investigate on your behalf the corruption and scam going on at IMM.

Why is everyone digging at Tim. He only been on the CEO job for two months. There's a lot of dumb a... people on this board who doesn't understand a simple corporate structure.
The CEO runs the company and make decision on everyday basis while the Chairman oversee the Board and a spokesman to the shareholders.
I must admit there might be some overlap of responsibilities on this small AIM company.
But a matter of truth, Tim was the Chairman until recently and Dimitriou was the CEO.
The company has not done much in the last few years and the share price plummeted and everyone blaming Tim for that. Just who was running the company.
In the latest interview, Tim said you can't run a company on a one product. Sound to me his having a go at his predecessor. Yes it was Dimitriou, probably a lame duck do nothing CEO.
Tim is now the boss the CEO and things beginning to get moving and it look to me he has done more in the last two months than Dimitriou in the last few years. Only time will tell.

Everyone seem to be concern whether phase 3 will be granted. My concern is when phase 3 does get under way how fast can they recruit the patients. Hope there is enough lupus patients in the US who have not died of covid-19.
Imm said the trial should last up to two years similar to their first phase 3 trial. Investors must be prepared for this to be a slow burner and add another year or so on top. All because of covid. Had it not been for covid we would probably be half way through phase 3 by now. It isn't business as usual, that's is why we still waiting.

And who brought up the subject of French speakers. Sounded to me Nolupus was saying IMM was on a racial profiling discrimination agenda to kick out the French speakers. Besides were they all French speakers as their natural language?

dallo,
I'm not targeting specially you but in general, few others have been saying it too about conspiracy Avion is behind it. Saying for example Avion and IMM are in disagreement about the trial design etc,etc. What do you do if this was the case. You go and oust the Board and the CEO of your licencing partner. So this is normal practice in the world of licencing partners pharmas . Is it? Never heard of it. What utter nonsense.

Avion and Acella behind? Come on, think simple. In this typical capitalist corporate world its the institutional investors shareholders (of IMM) for crying out loud. My bet leading this are Lanstead who after pushing out Dimitri instated Tim McCarthy as CEO. Now in my opinion Di Muzio and Mery who are going out too, may not necessary been pushed out. These two were brought in under Former CEO Dimitri. They would have said to themselves if Dimitri going so will we, out of loyalty to Dimitri. We will never know. In my experience and opinion Avion have got nothing to do with this.

If Lupuzor does really generate £1 billion worth of revenues and based on Avion deal and all other potential pipeline deal then IMM market cap would be worth £500m and that just to be conservative imo.

Sorry if others have misinterpreted what I posted earlier on "The question here now is, will Avion take out IMM?" What I meant was after the phase 3 result is read out and it is successful, IMM shareprice would go up tenfold at least. It is after this point would Avion take out IMM and not literally right now.

Who is going to buy IMM? if IMM does a licensing deals for the rest of the world on their Lupuzor and on their BioGlugon, BioAmp-B and CIDP indication, each with different pharma company, then it is highly unlikely IMM will be bought out but I'm not saying it won't happen. In this industry, it is normally the larger licensing pharma take out the small partner to take total control of the drug because it makes financial sense rather than pay for the drugs lifetime royalties. No major pharmas will buy IMM and play second fiddle to a minor because they are only buying IMMs royalties deal. A speciality pharma or a private equity firm maybe, for IMMs royalties but not from a major pharma. Now let assume IMM does no licensing deals on their rest of the pipeline and the upcoming phase 3 is successful, what will IMM be worth? The question here now is, will Avion take out IMM? Have they got the financial muscle? Can they afford it? Avion is private company so their finances are unknown. Will they go public and list themselves to raise the fund or will they borrow and put themselves in heavy debt?

Immupharma announced their first patient dosing in Feb 2016. P3 trial result was out in April 2018. The trial itself was finished months before the result was made public. The recruitment took a lot of time and it's the last patient dosed that count. June 2015 start date on Clinical Trial website was the registration and setting up stage. Do your research and do it properly.