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Any volume and this is going to go into orbit, get the feeling this is a coiled spring, FDA news over a year in the making, with Avion running and funding the phase 3 trial if we get approval it should also bring in some of the US pharma buyers as Avion are incredibly well respected in the US and very experienced in gaining FDA approval. IMM also retain worldwide license rights outside of the US, I can see multiple licensing deals materialising around the world once we get this FDA approval, exciting times ahead
What a difference a week makes. Fingers crossed that we get the anticipated update from Avion next week……I’m thinking a retest of the recent high at 32p…….albeit that was 2 years ago
Should see 20p minimum on FDA news, possibly more as it moves fast on any volume as we saw when the Avion deal was announced, huge week coming up
The FDA will inform Avion of their decision, Avion will then imo hold a board meeting to discuss the approval document and ratify the trial design and start dates for patient recruitment etc. If FDA did give their decision last week as previously started then Avion would have used this week to review the document and ratify it at board level and be ready To inform IMM next week. My thinking would also be Monday morning rns, a rise back to 20p would be reasonable given it derisks IMM for the phase 3 trial period. As we know during the last phase 3 trial the market cap hit over £300m… so from a £20m Mcap of history repeats we are looking at a 15 bagger from these levels and this time we have an experienced US partner who knows exactly what they are doing and have strong links and success with the FDA, GL all I feel next week will be a fantastic week
Going to take a guess that they'll get informed today and Monday morning RNS it must be getting closer
Are the FDA really going to refuse a phase 3 trial that has already been proven safe? Lupozor has a proven safety profile, never underestimate the importance of having a US partner where the FDA are concerned! They hve dealt with Avion numerous times before and approved their drugs for use. I added another £12k today, will add more tomorrow if I can get some sub 8.8p. GL all
Dallo,
Binary outcome... but I would suggest that the "probability" of a good report is higher than that of receiving a poor report...given all the constant positive discussions....
Lambo
It is a binary outcome
FDA approval then happy days.
Refusal we are not to going to be happy at all.
Squeaky bum time I am afraid.
ATB
Mike, the FDA wanted the PK study to be completed which delayed things by 5 months and Covid delayed everything for all pharma companies since March 2020! not just IMM and Avion. Avion and IMM have been in constant discussions with the FDA for the last year on the trial design, if the FDA had indicted in their December meeting that they wanted the Trial design to be different to what was proposed then Avion would have just pulled out there and then if they were not happy. They would not have gone to the expense and effort of doing the PK and all legal paperwork, hire new staff to work on this trial to then abandon it. In my opinion Avion want to be in full control of this trial hence the reason for the two company founders resigning from the board of IMM over the last few months, but crucially locking in their shares until the phase 3 trial is complete. If we get FDA approval and Avion set out their plans for the trial to start over the next few weeks and months this will fly to 20-30p imo such is the potential of Lupozor. We are talking about a multi billion $ market in the US alone, not to mention the rest of the world. Avion are no mugs, they are experts at working with the FDA and have had many drugs approved, Avion are willing to pay $25m for access to potentially licence Lupozor in the US whilst paying IMM $70m and double digit royalties on all sales. If they gain FDA approval once the phase 3 is complete IMM will be worth hundreds of millions, as I hve said before probably the only aim listed share I can think of that has the potential to 50 bag within the next 3 years if everything goes to plan…. Let’s see but if Avion believe in it then so do I
Mike
You could be correct but we will see.
The FDA decision will be based on the safety and efficacy of Lupuzor and the fact that Avion are apparently willing to spend $25m dollars on a Phase 3 trial should persuade the FDA that it is worthwhile as Lupuzor has been proved to be safe and has efficacy in Lupus patients with Antibody positive characteristics.
All is not lost yet.
It is July 2021 but every time IMM have been late with their RNS's it's been bad news. And as said earlier Avion are probably working through their action plan and looking at the costs involved especially if the phase 3 study is going to be longer. If it is bad news then the company will say that is why we have made the recent personnel changes. Its worrying times I knew I should have sold when the partnership with Avion was announced in Nov 2018 I had a healthy profit then but I believed that Avion were going to drive it forward quickly. The delays have been dreadful and probably shows how bad IMM's data was when Avion started to get into the detail more. Fingers crossed it good news for all shareholders.
Maybe meant approximately end of July 2022 :-)
Please Mister Postman, look and see
If there's a letter in your bag for me
(Please, Please Mister Postman)
Why's it takin' such a long time
For me to hear from that company of mine
My guess is 0700 tomorrow if not Friday or next week but it'll be a 0700 rns I'm sure off because looking back at majority of announcements its usually first thing . 50/50 chance what way it'll go
4th August and still no news of the FDA report ...is the report now sitting on someone's desk ,( waiting to finish the last page.)...until September .....??...
are we doing a Bob Marley and "Waiting in Vain" ?... should we change the record to Earth, Wind and Fire's "September" ???
IMM hit £300m Mcap during the last phase 3 trial… this time they have an experienced US partner in Avion funding the trial which I may add is huge in terms of favourable outcome with the FDA given it’s a US company. I fully expect an Mcap of £150m-200m during the next phase 3 trial if we get the go ahead. If the trial is successful and we get FDA approval then it’s blue sky potential globally for multi billion revenue given IMM still have global rights for IMM outside USA and within USA they have $70m of milestone payments to come from Avion and double digit royalties from sales in the US. Not many if any shares on aim offer this sort of potential reward from a £20m Mcap with a New management team, new US partner funding and designing the trial this could be something very special
Filled in those trades
Let's hope at some point you get back up to your buy in stage of £1.70 after successful trial could possibly happen
So where's this buy order of yours you've been telling us about lambo?
Yes that's the 430k order which was showing on level 2 being filled - was snapped up in about a minute!
Those large prints around 8.4p are all buys, something definitely brewing the last few days, volume increasing substantially today… it’s coming
All, I know I have to be patient and trust more but I've been in Imm for many years one of the first shares I bought back at £1.70 and my heart would like to get to a £ again but I've been let down so many times.
Here’s your chance to buy - someone wanting to sell 430k at 8.4.
Unfortunately nothing is always on time I've been in several shares where in same position results approx dates and overrun. Just have to wait not under imm control
Avion could have already received the FDA response, they may just be finalising the trial design at which point they will inform IMM, that’s what the last rns says. Remember Avion are a private company, board changes last week and the appointment of former AVO CEO were done for a reason. My buy should show up today and very pleased I got the opportunity to buy back in at these low levels with FDA news now literally due any day