Immupharma Share Discussion Threads

[criticalthinker1] 07/10/2022 17:45

Today's 'immediate' company secretary change o chartered accountants raises a few questions.
Not sure where to start following the over reaction to the FDA decision.
I've seen this a few times.
It normally involves money.
I expect another RNS next week ..but what? Takeover...merger...New coffee machine....something is afoot here.

[nobbygnome] 07/10/2022 07:01

>> mcdermov

Well I need more data to come to a definitive conclusion. However the experiments they did suggested the drug concentration should be at least ten fold higher than can be achieved with the current dose although there were various assumptions in my calculations. I would probably go for more frequent dosing rather than one big dose monthly.

[david gruen] 07/10/2022 05:54

He also suggested a suppository version, with a girthy sausage-shaped applicator. Apparently it makes all the difference.

[david gruen] 07/10/2022 05:52

"Take two pills four times a day before meals" was his latest suggestion.

[mcdermov] 06/10/2022 14:47

Nobby what do you think the dose, frequency of administration should be?

[nobbygnome] 30/9/2022 09:03

Years. My first post on the issue was September 2017

[david gruen] 30/9/2022 08:57

I can confirm that Nobby has been highlighting his dose issues for many months.

[sicilian_kan] 30/9/2022 08:39

Perhaps the solution is to just go straight in with Gen 2 - better drug, longer patent life etc. Gen 1 is surely dead if they have to go back to P2.

[nobbygnome] 30/9/2022 08:34

Yes that was my thought. They do have some data with 1000ug monthly but more frequent dosing is the way to go IMHO.

If a phase II is required then the drug is effectively dead because another 2 years would be added to the development cycle and I’m not sure Avion would pay for it. Avian’s naivety in this field is showing itself…

[sclper] 30/9/2022 08:15

"The FDA response earlier this month, recommended assessing the potential to use higher dosing in the next clinical program of Lupuzor™ in Lupus".Presumably another Phase II trial will be required

[base7] 30/9/2022 08:08

Arent Avion most likely to bid for IMM if they believe that Lupuzor will,eventually, be approved.

[david gruen] 30/9/2022 07:59

Lupuzor(TM) Update

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, provides an update on Lupuzor(TM), following the Company's recent announcement on 14 September 2022, that its US partner for Lupuzor(TM) (P140), Avion Pharmaceuticals ("Avion"), had received a written response from the Food and Drug Administration ("FDA") to the Type C meeting.

In summary, the FDA response earlier this month, recommended assessing the potential to use higher dosing in the next clinical program of Lupuzor(TM) in Lupus, to optimise the clinical benefit to Lupus patients and to maximise efficacy. In addition, the FDA made additional recommendations on clinical measurements, again to support Lupuzor(TM) through the regulatory process to approval.

Since then, both ImmuPharma and Avion, with their clinical and regulatory teams and advisors, have been reviewing in detail the FDA's written response and recommendations.

Further details on the next steps for Lupuzor(TM) will be communicated to the market, once finalised between ImmuPharma and Avion.

Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma said:

"Following receipt of the FDA letter earlier this month, we welcome the helpful recommendations from the FDA on the next steps in the Lupuzor(TM) clinical program. We equally recognise shareholders' frustrations on what is a very complex regulatory process, which is having an impact on moving Lupuzor(TM) forward. However, we are working very closely with the clinical and regulatory teams at Avion to accommodate the FDA's recommendations and decide on the next steps. We will update the market as soon as we have further guidance to share."

[neo26] 30/9/2022 07:37

Avion are still on board, mkt cap 8m, drug that works.We all knew there will be delay but a drug to hav potential for 1bn dollar sales per annum should be worth more.

[nobbygnome] 30/9/2022 07:34

So it’s been confirmed today the FDA want a higher dose of Lupuzor. I think this is an appropriate time to say ‘I told you so’…..about 5 years ago!

[neo26] 29/9/2022 18:06

It is indeed, even if phase 3 is delayed.

[criticalthinker1] 29/9/2022 16:45

This company share price is being played.
The share price is way less than what it is worth!

[neo26] 29/9/2022 09:07

Well we are all resigned to the fact phase 3 will be delayed for at least 12 months.Big pharma want there drug to make money rather than imm, can be possibility....

[lord loads of lolly] 28/9/2022 15:05

jambamthankyouma'am - and I heard you make it up as you go.

[nobbygnome] 28/9/2022 13:45

I see your last post on this thread was on 6th September and said

yep, RNS tomorrow approval


Hmmmm, shall I believe you?!?

[jambam] 28/9/2022 13:30

heard an update is coming shortly

[dr biotech] 28/9/2022 11:14

Unfortunately even if you knew how it worked you’d still need all the tests as it may only work on some and it may also have undesirable side affects in only a small subset etc.

Generally there are 3 stages (phases) to a trial, PI looks at safety only in a handful of people. P2 looks at safety and efficacy in a larger group typically 50-200 depending on what it’s for. Then P3 that looks at 1000s - efficacy and safety. This may pick up small subsets that are vulnerable etc. I don’t see anyway of avoiding this.

There is also P4 which follows large numbers of patients for some years after approval and will pick up long term side affects. You may have read some antivax guff about the covid vaccination not completing clinical trials as it hasn’t finished P4 - sort of correct, but totally misleading.

Apologies if you know the above. Just a casual observer here, I wouldn’t trust TMcC with any investment his record is terrible.

[nobbygnome] 28/9/2022 10:13

>> llol

I don’t think you have to be a shareholder to post comments here. As you know I am fascinated by this drug….

[colsmith] 28/9/2022 10:05

Nobby I was merely making a point that in reality the means to approve new Drugs is a gamble. Curranty the formal approval is based on statistics and not a absolute understating how the stuff under test operates on the body. If that were known then statistics aren't needed. The mice test merely shows this to be true, and of course animal bodies and human bodies operate differently I guess, for example my German Shepherd although likes chocolate can't process it; so even early animal tests are iffy and probably only show that the stuff under test is unlikely to kill. Its time to review the practicality of testing; still it raises an interesting point - how can a mice test(for final approval before humans take it) be ok to give the stuff to people and a formal stats test for P3 needs significant change even before it can start - its all snakeoil? Its a bigger issue than IMM's product.

Finally its said there are lies, damn lies and statistics. Weather stats perhaps a good example - where Met office give a 5% chance of rain - they can never be wrong!

[chesty1] 28/9/2022 09:33

This is another dead dog stock.

[lord loads of lolly] 27/9/2022 14:28

nobby - you told us you'd sold out immediately after the FDA's announcement, so why are you bothered? In fact, some might question why you're still posting here at all?