Immupharma Share Discussion Threads

[the stinger] 13/8/2021 12:59

People need to listen to the last 2 interviews on their site.

[colsmith] 13/8/2021 10:17

I said over and out until next RNS but as an opinion (not worth much) that to me suggests: if the FDA believe the odds are that the stuff works then I can see why, if there is an interest somewhere to delay getting to market, then that supports the view that this is the reason for the protracted timescale; conversely if the FDA consider the stuff has little chance of success then progress quickly to get it off the job sheet. Its a toss of a coin, as we only see this thru dark glasses, but why delay something if it has the effect to improve people's lives - or is that the number of people affected is relatively low as other drugs with a much higher market so to speak are at F1 speed; and that's the reason for delay - its low priority on the list of stuff the FDA work on.

Then there is - as the CNRS consider the stuff has a much wider use than Lupus that raises a viewpoint that in some way someone is interested in that market and see IMM as a commercially attractive proposition.

Pointless ramblings but depending on ones view on this its either a good bet on share price upside or it really is a shortens opportunity; to me the delay suggests it, in "someone's eyes", has a good chance of success or a takeout at a low price.

Sorry but really a last post for now; have a nice day

[the stinger] 13/8/2021 08:07

My 25p target is looking good.

[brad44] 12/8/2021 23:24

You don't need to be a "pretend doctor" to know that.IMM are confident, Avion are confident and so am I See you guys in 8 weeks

[eva_1989] 12/8/2021 21:42

Halfbuttt,

Feel like stuck here. But I’ll take a break now from posting till we cross 12p or we bust.

Adios!!!

[nobbygnome] 12/8/2021 20:42

They tend to do males because you,get more consistent results. The menstrual cycle means there is more variability in women.

[harleydocman] 12/8/2021 18:59

Nobby,

Why do you think they are doing this phase1 trial on only males ?

Seems very exclusive to me but they must have a good reason for this criteria ?

[halfbutt] 12/8/2021 18:57

Eva hang in there my lovely

[supernumerary] 12/8/2021 18:54

From Col Smith's post 37288:

'Extract from link of 9th February--

In response to the FDA input, Avion, in partnership with ImmuPharma, has plans to develop and validate a bioanalytical assay, to confirm the clinical pharmacology and pharmacokinetic ("PK") characterizations of Lupuzor(TM), prior to commencement of the Phase 3 trial.'

So is this preliminary phase to confirm the pharmacokinetics, or merely to validate the method of assessment that will be used in the P3? I still don't think we can answer that question with certainty. If it's the latter I think it unlikely we'd get an answer to Nobby's half-life question.

[the stinger] 12/8/2021 18:40

News / update soon

[nobbygnome] 12/8/2021 16:58

Or even another way what result will prove I am wrong and they are right or vice versa?

[nobbygnome] 12/8/2021 16:56

s_k

To put my point another way because sometimes I know I blind people with science. What would be classed as a positive result and why?

[nobbygnome] 12/8/2021 16:52

>> Eva

I am pleased you said 'crooked Tim' because I couldn't possibly comment!

[nobbygnome] 12/8/2021 16:50

>> s_k

With all due respect it's not going to address my questions at all. We will get an answer from the PK trial about the half-life and other PK parameters such as volume of distribution. The half-life might be 2 hours it might be10 hours but what you can be sure of is that they won't be able to measure any after the end of the first day. And the concentration in the blood will never be as high as that used in the experiments to show an effect. So the question remains how on earth does the drug work when there is nothing present for 27 days of the dosing period and the systemic concentration is not high enough to see an effect?

The bottom line is that the PK study changes nothing; they will just get the answer that the half-life is very short. But as I say if it's two hours or ten hours it's still bad news! I always said a PK study is pointless with regard to this trial and really it just shows the FDA are concerned.

[eva_1989] 12/8/2021 16:40

Flavio - I know.

But this is what it is!!!

Give me any RNS news from last 1 year other than this drama of FDA.

Let me tell you - none.

Did we hear anything other than Lupuzor news from crooked Tim ?

[flavio_monteiro] 12/8/2021 16:34

You are WEIRD Eva_1989!

....You own 1.2% of Immupharma and you come out with a statement -

"IMM have no other product in pipeline other than lupuzor".

Checkout their website..www.immupharma.co.uk.

[eva_1989] 12/8/2021 16:18

Almost 6% down.

Aa expected this was a negative RNS for the shareholders.

Guess now back to sleep until 3-6 months as IMM have no other product in pipeline other than lupuzor.

Could see 7p at this rate

[eva_1989] 12/8/2021 16:04

Excellent post Sicilian..

[sicilian_kan] 12/8/2021 15:48

Hi all - busy today and also wanted to think about things before posting.

In my view, this is a good thing for shareholders. There has for several years now been an argument put forwards by nobby about the dosing. That argument would hang over the Phase 3 trial, suppressing the share price, without the point being explicitly addressed.

Now, we will all know very shortly whether the company is right (and nobby is wrong) or whether nobby is right (and the company is wrong).

If the PK results are positive, and the company believes they will be, then that will be a massive boost to the Phase 3 (coupled with the already strong positive reaction in the anti-dsDNA patients). With a positive PK study, shareholders will have much more confidence during the P3 that it will be a success.

By contrast, if the PK results are negative, and if nobby is right, then we will at least know as soon as possible, without $25m of Avion's funds being wasted, and importantly without Immupharma's annual running costs being wasted on Lupuzor. Instead they can be focused on another part of the pipeline.

I see that some of the doom merchants are saying 6 months of delays to the P3 including going back to the FDA thereafter. But the overall figure doesn't matter at all, because the results of the PK study will be announced as soon as they are known, not once the FDA has reviewed them. And we know that the PK study will only take 8-12 weeks to complete, once started.

Also for those talking about the difficulties of recruitment, I think they are also missing the point. Immupharma is only targeting healthy subjects, who are of course much easier to find than those with lupus.

[the stinger] 12/8/2021 15:32

1ultimate - Pratt

[dr biotech] 12/8/2021 15:22

Used to get 10 years exclusivity regardless of patent expiry. I assume that’s still the case.

[the stinger] 12/8/2021 15:19

Once they spend up current cash... it's administration

[nobbygnome] 12/8/2021 15:08

>> OT

The dose in the phase III was 200ug and should be the same in the upcoming one. And all the PK study does is show the short half-life. That doesn't address the dosing issue.

>> harley

End of 2024 I would estimate but that means it won't be on the market until end of 2025 at the earliest. I have 2027 in my mind for the patent but that could well be wrong. Anyway I think they will get market exclusivity for a period of time but that could also be wrong as it's not my area of expertise.