George Frangeskides, Exec-Chair at Alba Mineral Resources, discusses grades at the Clogau Gold Mine. Watch the full video 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.
Laurence Reilly I should say
My phone is going bonkers tonight on fast text
Too old for this technical challenge..doh
A further interesting fact on the BMS takeover of Karuna is that BMS completed the deal in the knowledge that there are potential royalties payable to Puretech and Royalty Pharma of over $1billion..yes Royalty Pharma where our Non Executive Director, Laurence O'Toole is a Senior Vice President..
"...but there is a risk it will fail. "
It is all about reducing the probability of failure , and it is evedent many steps have be taken and decisions made, over many months to reduce that probability
Lower probability of failure is obviously teh, a higher probability of success
Avion clearly greatly involved in those decisions and steps, which although is a long process , means it more likely to be worth it....in the end
Cauldstream
Bristol Meyers bought Karuna Therapeutics for its Schizophrenia drug KarXT , for $14billion which got through Phase 3 trials and is awaiting final FDA approval in September this year.
The addressable market for Schizophrenia World-wide is c$6billion.
Should the FDA seek further tests in September then BMS is facing a problem of huge magnitude as the the deal is not contingent on final FDA sign-off.
This the world of international pharma who desperately need new drugs as , I have said, old drugs move out of patent protection and bog Pharma taking large risks to keep the party going.
Imho Dyor
"It's also been a considerable time since we have had any hard news on BioAMB's progress towards commercialisation."
At this stage I suspect there is just relationship building with potential interested parties monitoring the progress with commercial decisions coming once it has achieved a certain level of progress in its development stages ....the update in the March RNS was promising and positive
In respect of comparing Immupharma with others , I should say.
The question investors should focus on in respect of compareImmupharma is valuation .
Is Immupharma good value at a current market cap of c£7/8m given its late stage drug portfolio in addressable markets for Lupus and CIDP of over $6b combined compared to , say, Amolyt at a €1billion with 1 late stage drug yet to be approved by the regulators.
That to me is the investment thesis.
Each to his or her views but surely nobody thinks we are worthless as was suggested a few weeks back by certain punters
Time will tell
Dallo:
And if is bought by a large pharma, what valuation are we looking at? Amolyt cost AZN $1.05 billion. Can you imagine a valuation much greater than that for the P140 platform of peptides, £5 billion perhaps?
Flash
So what if it takes 3 years
Phase 3 drugs in multi billion $ markets are rare and sought after.
For example Amolyt Pharma is being bought for up to €1billion even though its only Phase 3 drug currently for Hyperparatyroid started trials in 2023 and topline results not expected until sometime in 2025 which is just over 2 years in trials.
Does any investor in Immupharma think the company will still be independent at the end of the trials for Lupuzor and CIDP.
Not a chance imho
Cauldstream7,
It's the Sponsors responsability and not the CRO to post anything on the clinical trials website ...
So don't blame it on Simbec
Nolupus:
Thanks for your comment.
I know that it is the responsibility of the CRO, Simbec - Orion, to post information about the timetable and other details of the Lupuzor trial on the clinical trials website, but surely they keep IMM and Avion up to date on their progress. They should pass on this information to private investors like us at regular intervals.
Cauldstream7,
We are all awaiting the GO signal, which IS the publication on the clinical trials website , of the Clinical trial protocol .
The protocol should inform us on estimated timescales, patient numbers etc etc
Until WE see this publication, everything IS open to conjecture, imo
Dallo:
Your last post was an important reminder of the correct situation in regard to the Phase 3 Lupuzor trial. Thanks.
Now, it would be helpful if we could be advised of the timings of the Phase 3 programme: when the patient recruitment will be completed; the likely spacing of the intermediate reports on the dosing regimes and similar information of the Phase 2/3 CIDP trial. It's also been a considerable time since we have had any hard news on BioAMB's progress towards commercialisation.
Loads picked this up from nobbygnome on the ADVFN board where both contribute.
IMM have not gone against FDA's recommendation. There's no evidence they did. Going straight into Phase 3 will still incorporate all of FDA's protocol as it were in Phase 2/3 adaptive study.
In a nutshell, in phase 2/3 they will stop briefly after 'phase 2' , report it, before moving onto 'phase 3'.
in Phase 3, they will do it in one go, no need of time delaying stoppages, therefore it will be quicker.
Rejection candle ,may exp a pb ...
https://invst.ly/140kl0
Jonah,
You are quite correct and it was the trial in Mauritius not Mozambique that eyebrows were raised over in the last Phase 3 trial.
The comments by Lord of Lolly are another example of some of the posts here recently saying that Avion and Immupharma went against the recommendation of the FDA in going straight to a Phase 3 Lupuzor trial.
This is totally wrong and deeply damaging to the company. The FDA asked for a dosing testing programme to be included in the trial as a proactive suggestion.
Initially Avion and Immupharma considered doing a short Phase 2 trial on a dosing regime ( over months) and immediately merging into a Phase 3 proper.
However after further review and consultation between all parties, it was considered that a full Phase 3 incorporating a dosage testing regime , the results of which would be released during a number of interim breakpoints in the trial. The FDA is apparently satisfied with this strategy and honestly does any rational person think that Avion is going to risk the wrath of the FDA and lose $25m by telling it to stuff its guidelines and advice particularly after 2 years of intensive discussions with the FDA.
Please contact Tim or Lisa to obtain independent clarification on this and any other matter.
Dallo, you are right to stress the importance of dose and formulation (BioAmb being a particularly relevant example for us) , though, of course, many of the latest immunotherapies are genuinely novel as is Lupuzor's mode of action. I also agree that there were problems with inclusion criteria, recruitment (very heavy on the Mauritius centre) and clinical end points. For instance, a drug that causes no symptomatic improvement compared tp placebo but which alows the clinician to drastically cut the dose of steroids the patient takes would be a huge step forward but would be classed a failure unless steroid dose was one of the predetermined end points. Let's hope we have learned the lesson from the first phase 3 study, though the positive phase 2 study it was based on was less than striking. I reckon they will have to develop a peptide that significantly prolongs life if I am ever to get my investment back here!
The FDA doesn't make recommendations in trial procedures and protocol but gives certain guidance to companies undertaking these trials.
The FDA wanted a dose ranging study done for Lupuzor which was the basis of the original Phase2/3 but after consultation between the parties it was decided to move directly to Phase 3 with a dose ranging process to be integrated into the new Phase 3 hence the delay , in part, in appointing Simbec-Orion as the trial managers.
GoldGirl - you should be aware they HAVEN’T totally taken the FDA’s advice on board in terms of the new trial protocol.
Going straight to another P3 trial is against the FDA’s recommendation.
Thanks everyone
dallo- that makes sense, and by taking fda/Scientists advise on board, Tim and team could turn this around.
Gla
Flash
You obviously don't know much about medicines and drugs.
For instance there has no new antibiotics developed since 1987, the treatment for Diabetes is still injecting insulin into the body after 50 years , Glaucoma is still treated by eye pressure reducing drops as it was for 60 years etc etc.
Where progress has been made in chemotherapy for instance, is that the sclentists / chemists have developed the ability to mix old drugs together to get better outcomes.
Lupuzor was successful in Lupus patients who were Antibody Positive Lupus sufferers but the trial included all Lupus patients including in Mozambique
where the trial cohort was badly run.
In fact the original Lupuzor trial was badly designed with low dosages and inadequate resources and management.
Following the the exhaustive discussions with the FDA and a total overhaul of dosages and patient selection et al the new trial is a totally different beast.
In relation to my previous post on Karuna's KarXt schizophrenia drug , this is a reconfigured therapy based on previous drugs but now has been modified to allow intravenous doses to be replaced by slow release tablets .
So nothing really new or novel in the world of new drugs but great strides made in adapting and reformulating old drugs in combination with other therapies and being able to get these combo drugs into the human body without causing the immune system to reject them...
That's what Lupuzor does for Lupus patients in its reformulated new dosage and drug transmission protocols agreed with the FDA and the scientists in Alora Pharma and Immupharma France.
Or this is what we hope will lead to a successful Phase 3 trial if all goes well....but there is a risk it will fail.
Cheers
Cauldstream
When I said Immupharma should have at least a £50m market cap, I meant after a commercial deal is done in the near term but the valuation should move much higher as the trials progress.
The World Bio Technology markets are coming back to life and the acquisition of Karuna Therapeutics by Bristol Myers for $14b for its Schizophrenia drug KarXT drug awaiting FDA approval in September this year is an example of the prices being paid by the majors as their existing drugs programmes go generic.
By the way KarXT was developed by Puretech, where I have a big investment, and from which Puretech is is set to make hundreds of millions of $ even though it offloaded the development risks years ago by setting up Karuna as a separate entity funded by outside funding and investors.
Sound familiar?
Cauldstream
When I said Immupharma should have at least a £50m market cap, I meant after a commercial deal is done in the near term but the valuation should move much higher as the trials progress.
The World Bio Technology markets are coming back to life and the acquisition of Karuna Therapeutics by Bristol Myers for $14b for its Schizophrenia drug KarXT drug awaiting FDA approval in September this year is an example of the prices being paid by the majors as their existing drugs programmes go generic.
By the way KarXT was developed by Puretech, where I have a big investment, and from Puretech is is set to make hundreds of millions of $ even though it offloaded the development risks years by setting up Karuna as a separate entity funded by outside funding and investors.
Sound familiar?
Cauldstream
My wife has a thyroid condition and she takes calcium tablets.
Hence I cannot see the logic in the Amolyt valuation but there you go.
So much I don't understand in this crazy world.
ATB