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Wildbunch:
Thanks for sharing the info you have from the AGM.
However, there are a few points within your info that are unclear to me
First. You say that IMM is advanced on finding a partner to manage Phase 2. Is this Phase 2 of CIDP?
Second, the statement of the Lupuzor 2/3 trial taking 3 to 4 years. OMG; that is much longer than I anticipated. And what does "Going towards 3 years "if outstanding date shown in Phase 3" mean?
Third, is "expectation rather than hope" a good sign? Do you mean that any agreement with a partner to finance the CIDP trial process, and/or a similar agreement with a partner to advance the ROW rights for Lupuzor, is likely to contain a clause to pay IMM a lump sum on signing of the agreement?
Fourth, the $5 payable on acceptance by the FDA that Lupuzor is an acceptable drug for use against Lupus is surely at least 3 or 4 years down the line because it will only happen after the 2/3 trial is successful. So how that does help any short term need for funding for IMM?
Wildbunch: Thank you. That is very welcome news. I hope you will have time to supply a few details in the near future.
Let's hope that happy days will come soon. ATB
Wildbunch: I totally agree with you. Like you, I emailed IMM a few days before Tim's latest interview to clear up the ambiguity (not that I saw any) over whether Avion would fund the 2/3 trial. To my mind that was never a realistic possibility; it would have been a clear case of cutting off one's nose if they had.
I suspect that many shareholders and non-shareholders who fulminate about Tim McCarthy realise that the FDA has made IMM and Avion jump through various hoops like the PK study before giving their approval to the new adaptive study and have also forced/persuaded both IMM and Avion to adopt a much higher dosage rate and frequency of administration than the two firms were advocationg.
But as Tim has said, it pays to listen and cooperate with the FDA who now seem to be in complete agreement on the road ahead. As Tim said in his interview, IMM could be on the cusp of a very major development which will be reflected in a large improvement in its SP.
No doubt I'll be accused of being a hapless stooge of the IMM cause. We shall see.
By the way, during that interview, Tim often repeated the phrase "few years", not "two years" when describing the passage of time between the original agreement between Avion and IMM and the present one. Nothing wrong with that is there?
At the very least, this interview should have silenced the doubters that the original agreement with Avion for financing the Phase 3 Lupuzor trial did not apply to phase 2 of the newly approved FDA adaptive 2/3 trial. I'm glad to have been proved correct that it would have been nonsensical if it had been so. Avion will indeed pay for the entire adaptive 2/3 trial and their preliminary costings indicate that the $25 million budget for the trial still looks sufficient to cover the costs of the new trial.
Lambo:
It has been emphasised by IMM that the FDA has approved an adaptive 2/3 trial, meaning that having determined the optimum dosage for client treatment in Phase 2, they can proceed to phase 3 without having to obtain any further approval from FDA. This would considerably reduce the time required to complete the combined trial.
In any case, Wildbunch will be at the AGM to ask Tim to give us a timeline for commercialisation of Lupuzor which would include the time required to complete the 2/3 trial.
Wildbunch:
I omitted the work "funding" from the first line of my first question .
Wildbunch.
If you do attend the AGM, please ask the following:
Where is IMM going to obtain from to meet its expenses over the period, (18 months?) until it receives its first contractual payments from Avion?
2. In his interview on the 24th May with Proactive Investors, Tim McC expressed his satisfaction with the great amount of interest amongst big pharma companies in partering IMM to commercialise Lupuzor in the Rest of the World outside North America. This is just the last of many similar statements so they are losing their credibility. Can he now put a date on when a deal will be signed with another pharma and will it include a downpayment to IMM to ensure its continuing viability as a going concern?
3. In the same interview, our Chairman said there was real enthusiasm amongst the pharma community for the potential of IMM's P140 peptide to provide improved treatment for CIDP. Another month gone by- where has all this enthusiasm gone? When will it result in a partnership with IMM?
Michael2021
In my opinion it's too soon to say that you will not get your money back if your average SP is 25. In the not so far distant past, that price would have been regarded as low.
Few if any investors back in 2018 before the failure of the last Phase 3 trial failure was announced, would have imagined where the price would be now. Even a year ago, with the price over 5p, I did not foresee that the price would fall below 2p. Let us suppose that the new adaptive 2/3 trial for Lupuzor is successful, not too fanciful a supposition, and that the CIDP trial is similarly successful within the same time frame, ie. around the end of 2024, a price of 25p will be in the rear view mirror. That is my expectation, and not just a forlorn hope as some might characterise it.
My main fear is that IMM's Board will recommend a takeover which will be at a SP below 20p which will leave long term shareholders like us out of pocket. I think this is still unlikely if the Lupuzor and CIDP trials are going well.
Nolupus:
It is clear that IMM and Avion have had to accept the FDA view that much higher dosage rates were required for the next adaptive 2/3 trial. I think they accept their past mistakes. Who could have known beforehand that their chosen dosage rates would be too low to treat some types of Lupus?
Were these mistakes arrogant? Perhaps, in that it would seem that it was only strong pressure from the FDA that persuaded IMM and Avion to accept these much higher dosage rates. I am no pharmacist, but the logic of the situation indicates that both FDA and Avion/IMM believe that Lupuzor now stands a good chance of success in the upcoming 2/3 trial.
Nolupus:
Thank you for your apology.
Thanks Frits for your encouragement. We all need that from time to time.
Actually, I do firmly believe in the strength of IMM's science and in particular its leader, Prof. Sylviane Muller. And I still continue to accumulate shares albeit on a small scale. So even if at times I despair, I still believe.
Is this what Nolupus defines as following IMM dogma?
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.
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.
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.
Nolupus.
To judge the importance of a scientific discovery by the number of employees involved in the lab and behind-the-scenes work is daft. One Sherlock Holmes is worth a 1000 plods on the beat.
In any case, P140 was discovered around 10 years ago by Prof Sylvane Muller so what does that have to do with current employee numbers at CNRS?
Nolupus:
My assessment of the relationship between CNRS and IMM is not overblown. I believe that it is not one of thousands of the same between CNRS and other companies. The agreement for the sharing of patents relating to P140 is of major importance and could have huge implications for the health of millions of sufferers from diseases of the immune system, as well as the earnings of IMM and CNRS through its licensing agreement with IMM for the P140 patents.
Oscar22.
I appreciate your analysis of IMM's strengths and the excellent prospects the company has of success in the use of the P140 platform in treating two autoimmune diseases, Lupus and CIDP.
Another reason (not mentioned by Oscar) to believe in the wide potential of IMM's peptide's platform, is the strength which the company derives from its exclusive right to commercialise the discoveries of France's principal scientific research institute, CNRS. And so, on its scientific team it has Prof. Sylvane Muller, one of the research directors of CNRS, and inventor of P140.
Eventually, and likely within 2 to 3 years, we can expect a further roll-out of the P140 as an effective treatment of other autoimmune diseases such as asthma, which have huge market potential.
Moreover, IMM's link to the CNRS, may ensure that IMM remains true to its mission to bring to market a wide range of treatments based on the P140 platform and prevent it from becoming an easy prey to large pharma companies with deep pockets.
Returning to Oscar's post, it would be a rash person who would contradict his evident confidence that Lupuzor will get FDA approval to proceed to a Phase 2/3 trial on the basis of its protocol and that the trial has a very good prospect of success.
Wildbunch: Like you, I have been very happy to let the short-term traders keep the price dotting up and down just above the floor. It allows me and I'm sure many others to accumulate bit by bit at absurdly low prices. Low anyway in my estimation given the hard science and experience behind P140 and its derivant, Lupuzor.
I'm obviously looking forward to the CIDP meeting with the FDA on 16 May and the Lupuzor meeting on 7th June for important positive news for IMM. Additionally, I am hoping to see an RNS about a financial and licensing deal with a larger, richer pharma to finance the Phase 2/3 trial for CIDP. That is the real trial of Tim McC's capabilities.
llofl: Let's look at the content of the last 3 RNS announcements. They state quite simply the steps being taken with the FDA to obtain approval for the protocols for the final Phase 2/3 trials of P140 adapted for Lupus and CIDP respectively. They signal progress not promises. I fail to see anything other than statements of facts from which I derive encouragement that these Trials will begin in H2 2023. Nothing misleading there.
How could the retreat of the SP have anything to do with either Tim?
Even a shallow understanding of where we are with Lupuzor and P140 should make it clear that the Tims have little to do with the submission of the protocols for these drugs entering into Phase 2/3 trials. In the case of Lupuzor, it is Avion and its scientists, aided by IMM scientists, who have prepared the protocols for testing the drug. If the Type C meeting on 7 JUne with the FDA does not lead to agreement with the latter, it will be Avion that will be at fault, not IMM or Tim McC.
Likewise with CIDP, the preparations for the meeting with the FDA on 16 May have been in the hands of Immupharma Biotech in France, not Tim in London.
What we are seeing is short term traders/speculators trying to make money out of small price movements. Some will succeed, others will lose, in equal numbers. What is clear is that they are NOT interested in the science behind IMM/Avion's design of Lupuzor trial protocols.
I wouldn't try to join in their games; I would be a minnow amongst sharks!