focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
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.
Cauldstream7, don't worry too much about the SP from day to day. I agree with your view that Avion and FDA are both keen to bring this on if they can safely and it is, in my opinion, just a matter of being patient - as always.
Nolupus.
I am sorry to have caused you pain by my comments. And thank you for clarifying the significant meaning of your nom de plume.
And for the record, I first invested in Lupuzor because I believed it held out real prospects of curing autoimmune diseases from which two of my children suffer.
I do not slavishly follow anything as you allege, and certainly not IMM dogma. You might explain what you mean by IMM dogma and cite some examples of my slavish following of it. Can you, and if not, can I have an apology?
I think that yesterday's RNS marks a significant milestone for Lupuzor and I'm surprised that the market's reaction is a damp squib. The only upside is that I can still add modest amounts to my shareholding without breaking the bank.
What I find most interesting is the evidence of a joint discussion between FDA and Avion/IMM about the trial protocols. There have obviously been compromises on the protocol. On the side of Avion/IMM there has been acceptance of the FDA's preference to take advantage of Lupuzor's safety record to use a much higher dosage rate for patients taking part in the adaptive Phase 2/3 trial. On the FDA side, they have accepted the preference of Avion/IMM for delivery via SC (as you have pointed out).
This collaborative approach suggests to me that there is now a much better chance of success in this new trial than in the Phase 3 trial in 2018.
....still, so any new punters can still jump on for the ride!
That is has been decided to finally use the SC administration method is very good news in the sense that it will facilitate patients and therefore be more marketable if approved , imo
Lambo222 - it's "you're" not your. And I'm neither sad, old or lonely. But thanks for your concern.
Cauldstream7,
I asked you nicely to refrain from personal commentary yet you persist and even amplify them !
You have absolutely no idea what I think about Lupus or any other thing for that matter …
I have peddled nothing but I have expressed my opinions on many occasions and will continue to do so , like yourself . Your track record is well documented here where you leave no room for anything but IMM dogma . I personally try to see the two sided coin and have been modestly accurate in the past but whatever , it’s more popular to bash Nolupus than to look in the mirror !
Btw my Nom de plume stands for No more Lupus rather than anything else ( for family reasons ) so I would personally like you to apologize for that if nothing else …
Lord… you do realise your a sad lonely old man? Just saying
Lambo222 - you do realise you've gone from "screaming buy" to "sell" to "long term hold" in the space of just 24 hours?
Woah-oh, the hokey cokey
Woah-oh, the hokey cokey
Woah-oh, the hokey cokey
Knees bent, arms stretched
Ra, ra, ra
It’s not the funding for the trial it’s the funding for IMM that investors are worried about, once the placing is out of the way and the price known it will become more attractive, long term hold now till the trial starts last this year
Nolupus:
You are a highbrow version of Lambo. You have been peddling doubts about the efficacy of Lupuzor for several years. Even your nom de plume seems to indicate that you don't believe there is an actual disease that goes by the way of Lupus. Instead, in the past your view seemed to be that Lupus is a syndrome of various illnesses that have similar symptoms but different underlying causes. Thus you believe they cannot be treated by a single treatment like Lupuzor.
In this latest case, Avion/IMM is being critised by you for what they have not said rather than what they have. Why would they have done so when for months they have clearly stated the a Phase 2/3 adaptive trial should be treated as a single trial, not two, because they can move on from Phase 2 to Phase 3 without obtaining any further permission from the FDA.
So don't tell us that your feelings have been hurt because I have called a scaremonger. When it has suited you that is the role you have chosen from time to time going back years.
What I understand is that nowhere has it been written that Avion are paying for this Whole P2-P3 trial ( full stop ) .
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?
FFs , who is talking about Avion walking away ??
All I said is that it has never been written that Avion are financing the full P2/ P3 trial !!
It is up to IMM to clarify these points !!
Cauldstream
Quite correct in your assessment.
Avion is part of the Alora Pharma Group, a $billion private company with 3 manufacturing and research facilities in Georgia , US and a host of drugs on the market primarily in the US.
If it was to walk away now after FDA guidance and approval of Phase 2/3 trials for Lupuzor and CIPD, it would be mad and leave the door open for a big Pharma to move in and takeover Immupharma with the total global rights to 2 late stage potential blockbuster drug therapies, something big pharma would find highly desirable and potentially cheap.
It is not going to happen but Immupharma is vulnerable to a bid whether from Alora who paid c11p for its shares in Immupharma or some other player.
The games have now started and Uncle Tim will try to do a deal if it is attractive to him and shareholders of which he is one.
Plenty more action to come and if Alora move it will have to be a lot higher than the 11p it previously paid.
Cauldstream7,
I am giving my opinion and not scaremongering !
Would you not think that IMM would have been delighted to say ´ hey shareholders, Avion’s are footing the bill for all this ‘ ??
As usual , everyone is entitled to their opinions but please refrain from personal attacks !
Nolupus-Thanks for your thoughts.
Nolupus. You are scaremongering when you suggest that Avion might not be prepared to finance stage 2 of the new adaptive 2/3 Trial. It has been stated in previous RNS announcements, that the adaptive 2/3 Study is the preferred option of Avion and IMM, instead of separate Phase 2 and Phase 3 Trials. Now that FDA has agreed to that and to the trial protocols based as much on the FDA proposals as on Avion's, it is inconcievable that Avion would now sit on its hands and
do nothing until a separate funder for the Phase 2 part of this new adaptive trial has been found.
How absurd a position to take when one considers the time and great expense that Avion has already spent in getting FDA approval to start the adaptive 2/3 trial.
Wild bunch,
Xviolet touched on this point , very clearly
What is stated is that we can count on Avion’s SUPPORT for advancing the clinical trial ( as par to the initial contract ) so no amendments have been signed since ?
So Avion signed up to finance a P3 trial yet there has been no amendment for the P2 part of this adaptive trial ?
If Avion were funding this part of the trial , I believe that IMM would have clearly stated this BWTFDIK
Yep 0.15% one step at a time TIM'' LOL!! perhaps another interview / podcast would help ? just thinking out loud, pay no attention
For those following the clinical side of things and not just the SP , well the major news out today was
That IMM will be using a SC formulation for the clinical trial and not a IV formulation
We have gone from a DC formulation to an IV formulation AND now back to a SC formulation
This is very intriguing and informative of the too and fro with the FDA , imo
Also
For those that are following things , one should go back a bit and see what Tim’s definition of starting a clinical trial means … ( he did mention in in writing not so long ago , if my memory is right :-)
Lambo222 - VERY odd you think "the market is too worried about a placing", given your top up this morning. As always, I followed your advice of 8.10am to the letter, as you promised an "easy 50% from here to be made today". Now I'm having to sell my right kidney before I can afford supper off Lidl's reduced shelf. IMM not impressed.
Knees bent, arms stretched
Ra, ra, ra
Stupid
market!!
Finished lower when they would be a good gamble now at double this SP.
NoLupus-what do you think maybe not clearly stated/left out?
Placing?
according to the RNS...
Avion Pharmaceuticals ("Avion") have confirmed that under the previously announced terms of the existing Licence Agreement, they will continue to support the new clinical trial design..."
so. if they are proceeding under the 'previously announced terms' doesn't that mean no little additional fundraise for this trial. but u think they might do a fundraise for something else? or is there something in the 'previously announced terms' that leaves plenty of room for a raise...oh...zzzz....zzzz....just 2 hot today to delve much deeper.