>> s_k
It’s a tragedy what has happened here because of something so obvious. McCarthy was involved all the way through so should shoulder a lot of the blame |
So I reckon the earliest date for submission of data for approval is now 2026…. |
You were right all along nobby, shame the company did not listen to you at the time. |
So there we have it, the FDA want a higher dose and a phase II or II/III is required. Ho hum…. |
Only 2 weeks overdue this rise.
Somebody knows something and did a shake. |
When will people learn |
colsmith - that's fine. You're just as entitled to your conspiracy theory as I am to believe the FDA's basically just trying to do the right thing to ensure long term P3 success. |
COLDSMITH, well said sir! |
Lord - re "short cuts. Playing with peoples health and life on a grand scale of billions, think not. proper industry procedures should have been followed. Some folks have suffered badly, OK a small % but if you are in the small % stats don't matter. Its all too glib, whatever is said about IMM's product it has been through the mill over years and has an extensive background.
I note MODRENA CEO is now recommending people under 50 don't take the stuff, although the CDC strangely still say 5 plus should take. Maybe the CEO is seeing some legal issues coming, who knows its all smoke and mirrors. Alternatively having used a market test the company now see where the stuff should be used, or is it that most have natural immunity now and pumping this stuff into a certain group cause more issues with the immune system
I guess we differ you see the FDA as working for the people I'm not so sure the mountains of cash in pharam can and probably do impact regulator decisions. |
colsmith - given the potential speed of impact from Covid & the sheer case numbers, there had to be shortcuts. Sadly, the same doesn't apply to Lupus or any other disease, however miserable the condition to sufferers. I think the FDA DOES want a positive outcome and is trying to steer IMM/Avion in the right direction to achieve it. But of course whether Avion's finances stack up in view of these extra hurdles remains to be seen. Sadly, IMM's don't! |
LORD you may be correct in that view but another P2 goodness the Covid stuff hit the streets big time and didn't do any formal pre test before release. OK may have done lab tests (and only mice on the latest booster) and some on people but to the standard? Its all snakeoil and dose levels - well like anything too much kills - water for example. If P2 is needed then its in lights the FDA are deliberately delaying, maybe they want a higher dose to show at that level its like too much water, if you get my point. We sit and wait but presumably Avion and IMM are deciding something - or is it a bit like a wall plaque I saw the other day "In 1832 nothing happened here". |
Yes, one of the FDA's central recommendations concerned dosing regime. Which presumably might mean another Phase 2 before the next Phase 3, as safety would have to be re-tested using this revised dosage? (assuming Avion are prepared to wait that long of course). |
Not sure how you say previous tests suggest ‘the stuff works’. The drug has never met a primary endpoint in any trial properly conducted to a conclusion. I maintain at the dose they are using Lupuzor is extremely unlikely to work and it appears the FDA agrees with me! |
 IMM may well have a good product but strategically the company are naïve. The US has been a graveyard for UK companies, such as TESCO, Sainsbury and probably many others. The one trick FDA shot or nothing was as I se it naïve as they are now as Lord says skint, or nearly so. Maybe they should have gone for a French company and seek EU approval at least that would have given another path. The share price is in the bog but maybe doing a deal with another company such as they had with TEVA years ago and CNRS are French would have been a good practical way forward even if some rights had been forfeited.
The real shame in all this is that if the stuff works for most people and previous tests, over years, suggest that is the case then patients are being hung out to dry by the FDA, who could have said, much as they did for COVID stuff, that wasn't tested to normal procedures but put on market to test on people , put on market on an emergency basis or whatever term the industry uses for market before P3. And if the side effects are minimal what is the risk provided of course patients are given the information in an open and honest way before agreeing to take. |
nobbygnome - thanks for the link. I've since found it's also available here without having to register: The terrible Tims did say they could already proceed to Phase 3, as the protocol had been agreed by the FDA. But they also said the FDA wanted a PK Study and that it was sensible to do this, as a) it doesn't pay to ignore - hence upset - your regulator & b) Phase 3 approval wouldn't be granted without it. I guess the same applies to where we are now. They could ignore the FDA's recommendations & plough on as is. But that would likely lead to yet another failed Phase 3, which IMHO would spell the end of IMM. So in my book, their future now basically hinges on whether Avion will countenance the delay & extra funds needed to comply with the FDA's additional recommendations. Someone on LSE implied Avion would proceed, as they'd have said by now if they intended pulling out. But I don't think it's that clearcut. Even if they do plan to keep calm & carry on, they're probably trying to negotiate more territories out of IMM as payback. And being close to skint, IMM really wouldn't have much option but to agree. |
In English? |
Look what landtead dudvfor VRS |
In fact with hindsight there are various ironic parts in the presentation. For example Tim talks about it being the right time to do the Lanstead deal because he was expecting the price to go to 30p which means the company gets more money…..ho hum |
I listened back and he did say the FDA gave approval a year ago….it’s about 48-49 mins into the presentation during the Q&A |
colsmith - saying they could progress a P3 regardless is NOT the same as saying the FDA had already given approval (which Nobby implies). Hence my request for a link to the interview in question so we can all listen to exactly what Tim said at the time. It's important because if he can be proved to have misled investors, there's a case for him to answer to the FCA. |
lord - I believe Nobby is correct - he did say they could progress a P3 but chose not to as FDA were gatekeeps (my words).
Tim should do an interview to update and whether FDA as Avion see it have a real issue with the proposed P3 plan; and if Tim was correct in what he said why an earlier FDA lot said it could go head. If its just more of the stuff pumped in why do the experts differ? There's strong evidence to support the view the stuff works such as the long pedigree from CNRS, and previous phases of testing, on the other hand like anything a singe test may fail whilst a second test with the same profile passes. I guess there are so many variables - such as have the folks on a failed test been on holiday on a 747 fight whilst on a previous test all the folks were at home during the winter; you get the meaning although the example is trivial. So an interesting question could be - if the previous P3 test were repeated what would be the results be - bearing in mind P2 passed.
I guess I'm a sceptic but the whole aspect of testing seems at best advisory and at worst gives the wrong result - be that a pas or fail. Maybe it would be the best of 3? Of course the gatekeepers hold the key like all these regulators and their decision may be based on many things.
Sorry a brain dump but this story has so many twists and turns - its like a computer game where the good guy just keeps being stopped by a villain jumping out of the bush. |
I’m not sure those were Tim’s exact words Nobby, though I agree he gave a very misleading impression. Do you have a link to his statement, so we can listen to it again? |
Strange that Tim hasn’t done another Proactive interview explaining his statement that approval had already been received from the FDA! The man is a charlatan…..and I wouldn’t normally make such a statement about a CEO on a public BB but in his case it is entirely justified! |
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