Immupharma Share Discussion Threads

[spawny100] 22/4/2022 09:30

I've also got a passionate hatred for IMM and lying Tim as I lost a fair bit of money here....... but I don't waste my time posting here every day.

[nobbygnome] 22/4/2022 09:29

>> colsmith

I am fascinated that you seem fascinated about me. I presume you are a shareholder so should only be concerned about what I write and try to counter the content if you think I am wrong. The reality is I know an awful lot about Lupuzor and the Pharma industry because of my long experience. If you think my views are not relevant, please filter me and then you don't have to read it.

Just to let you into a secret, my initial interest was driven by trying to justify to the company I worked for why they should seriously consider licensing Lupuzor following a conference presentation. But then I started doing some in depth research and also learnt various pieces of vital information from within my company. The rest is history and it really is a tragedy because there is a good drug here if it was dosed appropriately.....

[guy gibson] 22/4/2022 09:28

You won't realise what a bargain IMM is until we're at 50p+ later in the year.

[colsmith] 22/4/2022 09:17

Nobby - its fascinating as the extent you post on IMM, there must be a reason; such as:

- you believe folks must be told to ensure they don't waste cash on this stock;

- you don't like the company for some reason;

- you believe you really do know all about everything (about this subject) and must tell people because of ego.

- or something else.

I question this because whenever there is slight bit of good news you always come out with a negative post.

Anyhow that's my view; perhaps less posting would mean more and give a clearer message - the old wood and trees issue. Perhaps the best thing is to let things pan out - either P3 will go ahead and be successful or not. Personally the whole means of approving drugs seems fraught with more questions than answers - for example: Covid stuff was passed at the of speed of light for billions of folk to take and Lupuzor is stuck in the pits when only a few million or less are customers so to speak - odd.

[nobbygnome] 22/4/2022 08:38

Here is my post about the KOLs' views

The very good First Word Pharma information service, last month produced a comprehensive report on SLE KOL insight. They asked a large number of KOLs in Europe and the US to give their views on a variety of issues around the condition including pipeline drugs. The report makes very interesting reading with regard to the KOL's views on Lupuzor. Unfortunately you have to pay to get access to these reports so for copyright reasons I can't reproduce all of it.

However, I produce word for word the four, key insights on Lupuzor obtained from the KOLs.

1. Lack of clarity on Lupuzor's mechanism of action undermines confidence in this drug
2. KOLs consider Phase II study results for forigerimod to be questionable
3. KOL's remain cautious with regard to potential outcomes of the ongoing Phase III study
4. If approved Lupuzor will be reserved for second-line therapy in combination with standard of care treatments

They have numerous quotes from KOLs and the majority are negative although there are a few positive ones. I copy, below one quote from an American KOL which just about sums up the overall tone of the comments.

“The trial, it did have a good result but there was a strange inverted dose response with a higher dose working less well. It has all the hallmarks for something that may just be - it may just be a fluke. I think it's very courageous if they want to go and try it in a larger trial. On the one hand, I say, yeah, let's please try it and see. On the other hand, if you have to guess what is and what isn't going to work, I would probably not put my vote on this one.”

So guys don't shoot the messenger. This is the reason why the share price is going nowhere because the experts at the sharp end of this field have severe doubts about the drug. You cane be sure that many financial analysts will have access to this report and will act accordingly. I work with KOLs all the time and would be the first to take the view of any one with a pinch of salt because they can be very narrow in their thinking but their collective views should not be ignored. I am beginning to think that a rise ahead of the trial results is becoming increasingly unlikely because of this negativity in the field.

As I said above, don't shoot the messenger.....

Nobby

[nobbygnome] 22/4/2022 08:17

>> Pwhite

I burst out laughing about your KOL comments. I was integrally involved in KOL interactions for many years and I can tell you that you are clueless about how it all works. Every drug has an advisory group of KOLs and most drugs in a particular indication have a very similar selection of doctors. Do you think those KOLs are great advocates for all the different drugs? I can tell you they don't mince their words and can become your worst critic!

As I say you are clueless and naive about how Pharma works. I could dredge up the First Word report from a few years ago in which various KOLs expressed their negative opinions about Lupuzor. Since then they have been vindicated by the disastrous phase III results and I assure you their views will not have significantly changed......

[brad44] 22/4/2022 07:40

Well said PWhite73 Gobbygnome thinks he is such a know it all There was a lupus patient called Barbi Manchester an American lady, for whom the drug was apparently very successful

[pwhite73] 21/4/2022 22:48

Nobbygnome - "the FDA will never approve a drug which has a p value of 0.26 because that means the statistical requirement for a positive outcome has been missed by a country mile."

The new Phase III is an optimal trial meaning the candidates selected will be the ones who reacted best to the pivotal Phase III trial.

RNS 28/11/2019 - "With important insights gained from this pivotal Phase III Lupuzor™ trial, a new Phase III clinical trial design has been identified. The ability to select the most responsive patients by biomarker profile has enabled Avion and ImmuPharma to agree the most robust way forward for Lupuzor™ in lupus patients."

Nobbygnome - "I dare to suggest recruitment for this trial will be extremely difficult in a competitive indication because possible participants will Google the drug and see that it failed spectacularly first time around."

RNS 12/08/2021 - "Preparations will be made to commence the Phase 3 study, following completion of the PK study. For the continued late-stage program development, ImmuPharma and Avion Pharmaceuticals LLC ("Avion"), as part of a joint steering committee, agreed on a collaborative group consisting of a Board of Key Opinion Leaders ("KOLs") and a leading medical patient advocacy group. Collectively, this network, due to its in-depth knowledge of the lupus disease and their access to lupus patient groups, will be invaluable to the successful outcome of the Phase 3 trial."

Please try and stick to the facts and refute the company's announcements if you disagree.

[nobbygnome] 21/4/2022 21:08

Pwhite with all due respect (and I really do respect your views on many other companies) your naivety about drug approval is telling. Yes there has been some relaxation of efficacy criteria but the reality is the FDA will never approve a drug which has a p value of 0.26 because that means the statistical requirement for a positive outcome has been missed by a country mile.

Of course the proof of the pudding is in the eating but whatever happens it will be around 3 years before we all find out (assuming the phase III in SLE actually goes ahead)! I dare to suggest recruitment for this trial will be extremely difficult in a competitive indication because possible participants will Google the drug and see that it failed spectacularly first time around.

[colsmith] 21/4/2022 11:52

Sure is an interest somewhere - look at the AT trades.

[pwhite73] 21/4/2022 11:38

Nobbygnome - "you would have thought the phase III would be all ready to go.....but apparently not!"

They are not starting from scratch. This is a late stage Phase III trial. The bulk of the work has already been completed back in April 2018. It showed safety with no adverse effects but the efficacy was not significant enough from standard care alone.

As I explained yesterday what has changed is the FDA drug approval benchmark that is why they have approached the FDA again with a slightly tweaked drug. The FDA will grant approval this time round and allow clinicians to decide what lupus drugs to apply to their patients. They won't have an issue with Lupuzor as there are no safety or adverse concerns.

In fact the FDA can grant market approval before the Phase III study is even completed.

[nobbygnome] 21/4/2022 08:23

>> colsmith

I always find it amusing when other people try to dictate how much you post on a thread. You don't have to read what I write and indeed just filter my posts. Needless to say I will go on posting exactly as much as I want to try to counter the lack of understanding on this thread.

Another sentence from the RNS was 'We look forward, to working closely with our partner, Avion, on the next steps towards the Phase 3 study of Lupuzor(TM) in lupus patients, whilst we also progress our CIDP clinical program." Hardly seems like it is all ready to go then. After this protracted period of time waiting for the PK study to be completed, you would have thought the phase III would be all ready to go.....but apparently not!

[thordon] 20/4/2022 20:37

It was positive RNS - to be frank this is my wild card and looked at all other company's and this was in the right place at the right time.
A £3k investment at 6.5P , there are other company's taken punts and been mostly successful with a 3x return.
Then there's my conservative buying to balance out , dividends and slow growth.
Its a Balance
The other point is the other drugs in stage 2 , so not a one trip company if the stage 3 fails.
Investment in another company that has promise as well.

[pwhite73] 20/4/2022 10:26

I have no issue with Nobby on the thread at all and welcome every single post for debate.

Again from the RNS 13/04/2022 - "We look forward, to working closely with our partner, Avion, on the next steps towards the Phase 3 study of Lupuzor™ in lupus patients, whilst we also progress our CIDP clinical program."

If they anticipate or have reason to believe the FDA might block the 'next steps forward' then that again is a misleading statement. If Nobby is correct then the right thing to do would have been to await confirmation from the FDA that Phase III can go ahead before releasing the RNS on 13/04/2022.

[colsmith] 20/4/2022 10:22

I see Nobby has what could be said a passionate, to be kind, hatred of IMM; the huge number of posts made that in reality don't give most/any of us any useful info as to where Lupuzor will be going fiscally is pointless. The only piece missing in the recent RNS is that the FDA have yet to accept the results, which unless the company is lying have proved the PK test to be a good result, in which case the FDA, unless it is itself against IMM's product for some reason, will make clear the result is accepted and P3 progress is supported. So although you may have some good points in general you say it too often to be taken seriously IMO; please less of the thread time.

[pwhite73] 20/4/2022 10:11

Nobbygnome - "but are the results acceptable to the FDA.....that is what we don't know!"

If the results are not acceptable to the FDA then a sentence in the RNS 13/04/2022 is a blatant lie designed to mislead the market. In the absence of information to the contradictory than I for one accept the following sentence to be the truth.

RNS 13/04/2022 - "This positive PK data now clears the path for commencement of all clinical studies within the P140 platform"

[bobdown2] 20/4/2022 09:38

The above graph shows the delays that have haunted the share price. The relevant bit now is the placing where investors were prepared to pay 11 pence. There is roughly a 50% rise to those levels.
Once there other factors come into play. But you have to get there first. A read of the rns suggestd that that level could be achieved very quickly. Dyor.

[nobbygnome] 20/4/2022 09:37

So to be clear, the wording of that release is very clever. Yes it met its key endpoints in terms of being able to measure half-life etc but are the results acceptable to the FDA.....that is what we don't know!

[nobbygnome] 20/4/2022 09:35

I don't think you understand about drug regulatory issues. The fact that the FDA approved the PK study is irrelevant. The key question is why did they want a PK study done at all? Consequently, the results obtained in the PK study are absolutely key to the future of the drug but the company have kept investors in the dark about the reasons for the study and the results. Yes it might all be fine but there is a finite risk and this fiasco shows that IMM management are as dodgy as ever. McCarthy has been involved all the way through although he blamed everyone else for past mistakes; leopards don't change their spots.....

[pwhite73] 20/4/2022 09:23

Nobbygnome - No one is more cynical about AIM companies than me but one should never become a parody of oneself. That also applies to you.

The market for companies like IMM with a drug at Phase III stage has vastly improved both at the commercial and regulatory level. It is costly and difficult enough even to get to that stage. Avion worked with the FDA on the methodology of the new PK study and they approved it. On 13/04/2022 the company reported - "Data successfully demonstrates the PK study has met the key endpoints requested by the FDA".

Why you think the company and drug is dodgy is from evidence in the past but the company has moved on since then. Let's see what they have to say next but things are looking far better.

[bobdown2] 20/4/2022 09:16

Ignoring the very wide spread first thing. Trades have lessened today and buys are gaining the upper hand.,?. Does this share price move about on lower volume here for some reason.

[nobbygnome] 20/4/2022 08:53

>> bobdown

An interview with McCarthy never clears up anything; he is the master of obfuscation!

[nobbygnome] 20/4/2022 08:51

>> Pwhite

But the drug still has to work; Lupuzor has so far failed to provide any evidence that it does. Remember it has never met a primary endpoint in a completed trial yet.

I find it extraordinary that you have invested in a company with dodgy management and a dodgy drug. You are all over these boards pointing out to investors the issues about companies (often correctly) but then choose to invest in one of the most dubious of the lot. Yes you will make money in the short term if the phase III trial does indeed go ahead. However it would be good to hear that is your goal if it is the case rather than this disingenuous nonsense trumpeting the long term prospects of the company!

[bobdown2] 20/4/2022 08:36

I find that reading the rns statements a few times gives a better perspective than one persons continual take on the company. It can save lots of time if you get an aggressive poster.
What would be good would be an interview with the CEO on vox reports or similar. It would help to clear some of what some think is not what the rns actually says.

[pwhite73] 20/4/2022 08:31

Nobbygnome - "...Need I say more…"

Yes your technical knowledge is much appreciated here but you must also try to get to grips with the changing market place for drugs. Tailoring or targeting drugs for specific patients is now the modus operandi of the FDA and medical regulators as opposed to one size must fit all.

For example you have 100 lupus patients. Drug A is effective with 98 patients and drug B is effective with only 2 patients. The 2 patients drug B is effective on are the 2 patients drug A has no effect on. Previously the FDA would have failed drug B on the grounds of no significant improvement over standard care. Today it will not. So long as drug B has no adverse effects the FDA will allow clinicians to administer drug B to the 2 patients it works for.

That's the change that's happened in the drug market over the last five years. Lupuzor will be granted FDA approval that's why Avion have invested $25 million in it.